Acquiring urine characteristics and related systems, devices, and methods for providing fluid therapy
The fluid management system optimizes urination through urinary characteristic monitoring and personalized diuretic administration, addressing variable patient responses and reducing treatment time and hospitalization.
Patent Information
- Application Number
- JP2025545203
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-02-06
- Filing Date
- 2024-02-06
- Publication Date
- 2026-02-27
AI Technical Summary
Conventional systems and methods for treating fluid overload in patients do not accurately monitor a patient's urination and urinary characteristics, leading to variable responses to diuretic treatment, prolonged treatment times, and increased hospitalization due to uncertainties in urine production.
A fluid management system that includes a urine collection and monitoring system, automatic hydration fluid infusion, and diuretic infusion, controlled by a controller to optimize urination based on urinary characteristics such as volume, conductivity, and oxygen content, allowing for personalized diuretic administration and hydration fluid adjustments.
The system enhances the efficacy, safety, and efficiency of fluid management by rapidly assessing diuretic resistance, reducing treatment time, and minimizing side effects, thereby improving patient outcomes and resource management.
Smart Images

Figure 2026506881000001_ABST
Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 483,494, filed February 6, 2023, the disclosure of which is incorporated herein by reference in its entirety.
[0002] TECHNICAL FIELD The present disclosure relates generally to medical devices, and more particularly to systems, devices, and methods for acquiring and relating urine characteristics to provide fluid therapy. [Background technology]
[0003] The human physiological system naturally attempts to maintain a balance between fluid intake and fluid excretion. An imbalance between fluid intake and excretion rates can cause the body to retain an excessive amount of fluid, also known as fluid overload. Fluid overload can be caused by acute decompensated heart failure (ADHF), chronic heart failure (CHF), or other conditions in which fluid excretion is inadequate. Patients who exhibit fluid overload can suffer from shortness of breath (dyspnea), edema, hypertension, and other undesirable medical conditions. [Prior art documents] [Patent documents]
[0004] [Patent Document 1] U.S. Patent No. 11,633,137 Summary of the Invention [Problem to be solved by the invention]
[0005] To treat fluid overload, patients are typically administered diuretics to induce and / or increase urine production, i.e., to reduce the amount of fluid and sodium in the body. Urinary output rates can be carefully monitored and / or controlled for safety reasons, e.g., to avoid placing undue stress on the patient's kidneys. Different patients may respond differently to treatment, such that the same diuretic type and / or dosage may result in dramatically different urination rates. However, conventional systems and methods for treating fluid overload may not accurately monitor a patient's urination and / or urinary characteristics in response to changes in urination.
[0006] The features, aspects, and advantages of the techniques of the present disclosure may be better understood with regard to the following drawings. [Brief explanation of the drawings]
[0007] [Figure 1] 1 is a partial schematic diagram of a fluid management system configured in accordance with an embodiment of the present technology; [Figure 2] 1 is a flow diagram of a method of treating a patient configured in accordance with an embodiment of the present technology. [Figure 3] 1 is a partial schematic view of a urine flow cartridge configured in accordance with an embodiment of the present technology; [Figure 4] 1 is a partial schematic view of a urine flow cartridge configured in accordance with an embodiment of the present technology; [Figure 5A] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 5B] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 5C] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 5D] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 5E] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 5F] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 5G] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 5H] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 5I] FIG. 1 illustrates a representative example of a urine collection system in accordance with an embodiment of the present technology. [Figure 6] 1 is a block diagram illustrating a method for providing an output associated with a patient's fluid therapy, arranged in accordance with an embodiment of the present technology. [Figure 7] 1 is a block diagram illustrating a method for providing an output associated with a patient's fluid therapy, arranged in accordance with an embodiment of the present technology. [Figure 8] 1 is a block diagram illustrating a method for providing an output associated with a patient's fluid therapy, arranged in accordance with an embodiment of the present technology. [Figure 9] 1 is a block diagram illustrating a method for providing an output associated with a patient's fluid therapy, arranged in accordance with an embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION
[0008] Those skilled in the art will appreciate that the features shown in the drawings are for illustrative purposes and that variations are possible, including different and / or additional features and arrangements thereof.
[0009] I. overview The present technology relates to systems for managing (e.g., increasing or decreasing) a patient's urination based at least in part on characteristics of the patient's urine. Such characteristics may include urination (e.g., urination volume and / or rate), urinary conductivity, urinary sodium concentration (e.g., based at least in part on the conductivity of the patient's urine), urinary temperature, and / or urinary oxygen content (e.g., the partial pressure of oxygen in the patient's urine). Embodiments of the present technology relate to infusing a diuretic and / or hydration fluid to increase or optimize urination from a patient. While standard treatment protocols may be effective for most patients, some patients may have specific conditions that prevent or inhibit optimal therapy and / or may have an abnormal response to standard treatment protocols. By way of example, certain patients may not respond to some diuretics and / or may have underlying conditions (e.g., low or high blood pressure) that limit their urination rate or make treatment to achieve a maximum urination rate more difficult. For such patients, additional steps or protocols may be required to increase urination and alleviate fluid overload conditions. These additional steps or protocols may be based on data associated with the therapy the patient is receiving, such as the patient's response to the therapy (e.g., administered diuretics and / or hydration fluids), and / or historical treatment data, including one or more other patient treatment responses. Accordingly, embodiments of the present technology are expected to optimize and / or customize all or a subset of diuretic therapy to an individual patient's physiology, e.g., to maximize decongestant relief and / or minimize clinical sequelae.
[0010] As described elsewhere herein, embodiments of the present technology can manage a patient's fluid removal based on one or more of the patient's urination, urinary conductivity, urinary sodium concentration, and / or urinary oxygen content. For example, in some embodiments, the patient's urinary sodium concentration (and / or an indication thereof, including, for example, the patient's urinary conductivity) can be compared to one or more urinary sodium concentration thresholds (e.g., high urinary sodium concentration threshold and / or low urinary sodium concentration threshold) to determine one or more adjustments to the patient's therapy, such as, for example, diuretic administration rate, hydration fluid infusion rate, hydration fluid compatibility percentage, etc. Additionally or alternatively, the patient's urinary oxygen content can be compared to one or more urinary oxygen content thresholds (e.g., high urinary oxygen content threshold and / or low urinary oxygen content threshold) to determine one or more adjustments to the patient's therapy. In some embodiments, one or more adjustments to the patient's therapy can be based on a combination of two or more of the characteristics described herein, including urination rate, urinary conductivity, urinary sodium concentration, urinary temperature, and urinary oxygen content. Such combinations may include urination and urine conductivity, urination and urine oxygen content, urine conductivity and urine oxygen content, and / or urination, urine conductivity and urine oxygen content.
[0011] These and other embodiments of the present technology can manage a patient's fluid removal based on the measured urination volume and the physician's estimated excess fluid volume. For example, in some embodiments, if the patient's urination drops below a predetermined rate and the patient has lost 80% or more of the estimated excess fluid volume or less than 1 L of estimated excess fluid remains to be removed from the patient, the system may determine that therapy should be stopped (e.g., automatically stopped) immediately or after a period of time (e.g., 1 hour). Alternatively, if the patient's urination drops below a predetermined rate and less than 80% of the estimated excess fluid volume has been removed and / or more than 1 L of estimated excess fluid remains to be removed from the patient, the system may determine that steps need to be taken to increase urine production. In such embodiments, the system can recommend (e.g., via software, labeling, etc.) infusing a second diuretic in addition to a first diuretic already being infused and / or adjusting the rate of hydration fluid infusion. In doing so, embodiments of the present technology can advantageously manage a patient's urination by discontinuing one or more aspects of fluid therapy (e.g., diuretic infusion) in cases of sufficient fluid loss and improving fluid therapy by increasing urination in cases of insufficient fluid loss.
[0012] The headings provided herein are for convenience only and are not intended to limit or construe the scope or meaning of the present technology.
[0013] II. Fluid management system and method The present technology generally relates to systems, devices, and related methods for patient-data-based fluid therapy, which includes managing a patient's fluid levels based at least in part on data received from the patient before and / or during fluid therapy. In some embodiments, the systems, devices, and methods described herein are used to treat a patient for fluid overload. To treat fluid overload, the patient may be administered a diuretic to induce and / or increase urine production. For example, loop diuretics are diuretics that act on the ascending limb of the loop of Henle in the kidney and include bumetanide (Bumex®), ethacrynic acid (Edecrin®), furosemide (Lasix®), torsemide (Demadex®), thiazide and thiazide-like diuretics (e.g., chlorothiazide, metolazone), potassium-sparing diuretics (e.g., amiloride, spironolactone), carbonic anhydrase inhibitors (e.g., acetazolamide), vaptans (e.g., conivaptan), SGLT2 inhibitors, and osmotic diuretics (e.g., mannitol). Diuretics can be administered orally as tablets or as an intravenous (IV) injection. IV diuretics can be used when oral diuretics lose their effectiveness and / or cannot be absorbed.
[0014] The short-term effects of diuretics on a patient's urine production can be difficult to predict, especially early in treatment. For example, one patient may produce significantly less urine than expected for a given diuretic dose, while another patient receiving the same dose may produce significantly more urine. Low urine production can prolong treatment time and / or reduce therapeutic efficacy, whereas high urine production can raise concerns about hypotension, hypovolemia, electrolyte imbalance (e.g., hypokalemia), and / or vital organ damage. High doses of diuretics can also raise concerns about ototoxicity, regardless of urinary response. Due to these uncertainties, physicians typically prescribe a conservative (e.g., low) diuretic dose initially and wait several hours before considering whether to increase the dose. If physicians determine that a higher diuretic dose is required, they can slowly and piecemeal increase the dose until the patient achieves the desired level and / or rate of urination. However, this approach may prolong the time the patient remains in a state of fluid overload, potentially worsening the patient's underlying clinical condition. For example, a conservative treatment procedure may require several hours or even days before the patient's urinary output becomes high enough to cause significant fluid loss and relieve the fluid overload state. The patient may be hospitalized for several days (e.g., 4-5 days), which can be costly and burdensome. Additionally, long-term treatment efficacy may be limited, resulting in approximately 25% of patients being readmitted within 30 days for fluid overload.
[0015] To address these and other challenges, the present technology provides systems and related devices and methods for managing patient fluid levels. In some embodiments, the present technology can (i) improve the efficacy, safety, and quality of fluid management therapy, (ii) improve resource management in hospitals and other clinical settings, (iii) rapidly assess whether a patient has diuretic resistance, and / or (iv) increase diuretic efficiency (the amount of urine and / or excreted electrolytes (e.g., sodium) obtained over a given time period per milligram of diuretic infused intravenously). The embodiments described herein can increase the net removal of fluid and / or electrolytes (e.g., sodium and / or chloride), and also treat fluid overload conditions in a more efficient manner (e.g., with a shorter time frame and / or higher net fluid loss).
[0016] 1 is a partial schematic diagram of a fluid management system 100 ("system 100") for monitoring urination and / or controlling fluid infusion into the body of a patient P in accordance with an embodiment of the present technology. System 100 includes a urine collection and monitoring system 110 ("urine system 110"), an automatic hydration fluid infusion system 120 ("hydration system 120"), an automatic diuretic infusion system 130 ("diuretic system 130"), a controller or control system 140 ("controller 140"), and a display or input / output unit 150 ("display 150"). Controller 140 may be operably coupled to each of urine system 110, hydration system 120, diuretic system 130, and / or display 150. The system 100 may further include a console or structure 105 ("console 105") that incorporates, houses, and / or otherwise supports all or a portion of the urinary system 110, the hydration system 120, the diuretic system 130, the controller 140, and / or the display 150.
[0017] The urinary system 110 is configured to collect urine from a patient P and / or monitor the patient's urination (e.g., urination volume and / or rate). The urinary system 110 may include one or more collection containers 112 (“containers 112”) configured to hold urine, such as disposable bags or other collection devices. The containers 112 may be fluidly coupled to the patient P through a fluid line 119 (e.g., a tubing line). The fluid line 119 may include a single continuous fluid line or multiple fluid line segments (e.g., first, second, third, etc. fluid line segments, proximal and distal fluid line segments, etc.) that are in fluid communication with each other. The fluid line 119 may be connectable to a disposable catheter 118 (e.g., a Foley catheter, a Texas condom catheter, a PureWick catheter, etc.) placed in or otherwise connected to the patient P's bladder.
[0018] In some embodiments, urine flow through the fluid line 119 is driven by the patient's urine production, gravity (e.g., the patient P's bladder is positioned higher than the container 112), and / or a siphon effect between the patient's bladder and the container 112. In other embodiments, the urinary system 110 also includes a pump (not shown) operably coupled to the fluid line 119 to actuate urine flow through the fluid line 119 and into the container 112. The pump may be or include any device suitable for pumping fluids, such as a peristaltic pump. The pump may be used to initiate urine flow from the patient's body at the start of a procedure. Additionally, the pump may be used to clear air blockages and / or other obstructions from the fluid line 119.
[0019] The urinary system 110 may include one or more sensors 114 (“sensors 114”) configured to detect characteristics of the patient's urination (e.g., the amount and / or rate of urination, and / or electrical, chemical, and / or physical properties of the patient's urine, including, for example, urine sodium concentration, urine conductivity, urine temperature, urine oxygen content, etc.). As described in more detail below (e.g., with reference to FIGS. 3 and 4 ), the sensors 114 may be incorporated into a urinary flow analysis cartridge 101 (“cartridge 101”) configured to receive urine from the patient P. The cartridge 101 may include a flow channel fluidly coupled to a fluid line 119, and the sensors 114 may be positioned within the flow channel. Thus, as urine flows through the cartridge 101, the sensors 114 may generate data based at least in part on the patient's urine, and the controller 140 may thus monitor and / or calculate the patient's urination based on the data generated by the sensors 114. In some embodiments, the fluid line 119 may be directly coupled to the cartridge 101, e.g., to a fluid inlet thereof. Additionally or alternatively, cartridge 101 may be integrated with console 105, detachably coupled to console 105, incorporated into fluid line 119, and / or have another suitable configuration relative to one or more other components of system 100.
[0020] Urination can be determined in many different ways, such as based on urine flow (e.g., through fluid line 119, through cartridge 101, and / or into container 112), the amount of urine in container 112 (e.g., based on the weight of container 112, the level of urine in container 112, etc.), and / or other properties associated with urine. Sensor 114 can include one or more of a flow sensor, a drip counter, a fluid weight sensor, a fluid level sensor, a float sensor, an optical sensor, an ultrasonic sensor, and / or other sensors known in the art suitable for measuring the amount and / or rate of urination. In the embodiment of FIG. 1, sensor 114 is located in console 105. However, in other embodiments, some or all of sensor 114 can be located in different locations within system 100, such as on or within line 119, container 112, and / or patient P.
[0021] In some embodiments, the sensor 114 may include at least one sensor configured to measure one or more characteristics of the urine in addition to detecting the patient's urination. For example, the sensor 114 may be configured to measure urine temperature, urine conductivity, urine oxygen saturation, urine specific gravity, and / or the level of one or more analytes in the urine (e.g., creatinine, sodium, potassium, etc.). Such characteristics may be advantageous, for example, in determining the effectiveness of a particular therapy and / or in determining whether the patient P is considered to be in or approaching a critical condition. For example, urine conductivity and / or urinary electrolytes (e.g., sodium) may indicate whether the patient is responding well to fluid therapy or whether the patient is in a critical condition and fluid therapy should be discontinued. In some embodiments, urine conductivity (either alone or in combination with urine specific gravity) is used as a surrogate for measurements of urine sodium and / or other urine electrolytes; for example, higher urine conductivity may be correlated with higher urine sodium levels, and lower urine conductivity may be correlated with lower urine sodium levels. As another example, urine temperature measurements can be used to detect urine flow (e.g., based on heat loss between two ends of fluid line 119). Urine temperature can be used as a surrogate for the patient's body temperature, in which case urine temperature is believed to correlate with the patient's current clinical condition.
[0022] Optionally, the sensors 114 can include at least one sensor configured to monitor the status of the urine collection procedure, e.g., whether urine collection is progressing normally, whether there is an interruption in urine flow, whether there is an obstruction or leak in the urinary system 110, cartridge 101, etc. For example, the sensors 114 can include a leak sensor configured to detect whether there is a leak in the urinary system 110 (e.g., in or near the fluid line 119, catheter 118, cartridge 101, and / or container 112). A leak can be detected based on a change in urine flow rate, a change in pressure, the presence of moisture, or any other suitable parameter. In some embodiments, the controller 140 is configured to analyze data from the leak sensor and / or other sensors 114 to distinguish between a low urination rate and a leak in the urinary system 110.
[0023] As another example, the sensor 114 can include a pressure sensor configured to measure fluid pressure in the fluid line 119. The controller 140 can use the pressure measurements to monitor the status of urine flow and, optionally, detect whether there is any interruption (e.g., a decrease, a sudden cessation) or other problem associated with urine collection. In some embodiments, the controller 140 analyzes the pressure measurements to determine whether the interruption is due to low urine flow (e.g., the patient's bladder is empty or nearly empty), an air blockage or other obstruction in the fluid line 119, a leak in the urinary system 110, and / or a kink in the fluid line 119 and / or catheter 118. The controller 140 can alert the user if manual intervention is beneficial or required (e.g., to clear the obstruction, repair the leak, remove the kink from the fluid line 119, etc.). In embodiments in which the urinary system 110 includes a pump, the controller 140 can automatically activate the pump and / or increase the pumping speed to clear the obstruction from the fluid line 119.
[0024] Hydration system 120 may include at least one hydration fluid source 122 ("fluid source 122," bag, bottle, reservoir, etc.) that contains a hydration fluid, such as saline (e.g., premixed saline solution), lactated Ringer's solution, and / or any other liquid solution suitable for infusion into the body of patient P to prevent or treat dehydration. The hydration fluid may be isotonic, hypertonic, or hypotonic, for example, depending on the patient's condition and / or other treatment requirements. Optionally, the composition of the hydration fluid (e.g., sodium, chloride, potassium, bicarbonate, etc.) may be altered based on the patient's condition and / or expected or measured electrolyte losses during the treatment procedure.
[0025] Fluid source 122 can be connected to patient P through at least one fluid line (e.g., an IV line or other tubing), such as first fluid line 129a and second fluid line 129b. Fluid source 122 can be operably coupled through first and second fluid lines 129a, 129b to one or more hydration fluid components 124, e.g., a hydration fluid pump 126 and / or at least one hydration fluid sensor 128 ("fluid sensor 128"), for actuating and / or monitoring the infusion of hydration fluid. In the illustrated embodiment, fluid source 122 is fluidly coupled to hydration fluid pump 126 through first fluid line 129a, which can pump hydration fluid into the body of patient P through second fluid line 129b. Hydration fluid pump 126 can be or include a peristaltic pump or other pump suitable for infusing fluid into the patient's body (e.g., through an IV route or another route).
[0026] Fluid sensor 128 may be configured to determine the amount and / or rate of hydration fluid flowing from fluid source 122 toward patient P and may include flow sensors, pressure sensors, and / or other sensors configured to determine fluid output from pump 126. Alternatively or in combination, fluid sensor 128 may monitor the hydration infusion rate by measuring the pumping speed of pump 126 (e.g., the revolutions per minute of pump 126). As discussed elsewhere herein, controller 140 may be operatively coupled to hydration system 120 and may receive sensor data from fluid sensor 128 to determine the hydration fluid infusion rate. Controller 140 may control the pumping speed of pump 126 to control the amount and / or rate of hydration fluid administered to patient P.
[0027] Optionally, the amount of hydration fluid in fluid source 122 may be monitored based on, for example, weight, volume, fluid level, flow rate, etc. In such embodiments, fluid source 122 may be operatively coupled to additional sensors (not shown) separate from fluid sensor 128, such as a fluid level monitor, a float sensor, a weight sensor, an optical sensor, a drip counter, or a flow measurement sensor. The additional sensors may provide an independent source of measurement data for determining and / or verifying the amount and / or rate of hydration fluid being delivered to patient P, which may be useful for improving the accuracy of the measurements.
[0028] In some embodiments, hydration system 120 includes at least one sensor, such as a location sensor, an optical sensor, a weight sensor, or the like, configured to detect the presence of fluid source 122. Hydration system 120 can use the sensor data to automatically determine whether fluid source 122 is present or absent, thereby, for example, assessing whether system 100 is ready to begin fluid therapy treatment. Optionally, the sensor data can be used to detect whether a user attempts to remove fluid source 122 during a treatment procedure, for example, to switch from an empty or nearly empty fluid source 122 to a new fluid source 122. In such an embodiment, system 100 can automatically pause the injection of hydration fluid until fluid source 122 has been replaced. Thus, a user can switch fluid sources 122 without having to notify system 100 or manually pause the procedure.
[0029] Diuretic system 130 can be configured to automatically administer a diuretic to patient P. Diuretic system 130 can include a diuretic source 134 (e.g., a syringe, bag, reservoir, etc.) that contains a diuretic, such as bumetanide (Bumex®), ethacrynic acid (Edecrin®), furosemide (Lasix®), torsemide (Demadex®), and / or other diuretics known in the art, each of which can be part of a fluid solution (e.g., a mixture of saline and a diuretic or other medication). In some embodiments, the identity and / or concentration of the diuretic can be accepted by controller 140 by user input (e.g., with display 150), and / or by scanning a barcode on diuretic source 134 or other diuretic container, and / or by any other suitable technique.
[0030] The diuretic source 134 may be connected to the patient P through a fluid line 139 (e.g., an IV line or other tubing). The diuretic source 134 may be operatively coupled to one or more diuretic components 136 for actuating and / or monitoring diuretic delivery through the fluid line 139. For example, the diuretic component 136 may include a diuretic pump configured to pump diuretic through the fluid line 139 toward the patient P. The diuretic pump may include a peristaltic pump, a syringe pump, a metering pump, or other device suitable for delivering diuretic to the patient P at multiple dosage rates. The diuretic pump may deliver the diuretic according to any suitable delivery profile, for example, at a controlled continuous rate and / or in controlled boluses delivered at regular intervals through the fluid line 139.
[0031] In some embodiments, the diuretic pump is or includes a syringe pump including a mechanical syringe or plunger operably coupled to controller 140 such that controller 140 effects movement of the syringe to deliver diuretic to patient P. The syringe pump can include or be coupled to an actuator that mechanically drives the syringe to control delivery of diuretic to patient P. For example, the actuator can be or include a mechanical actuator, such as a nut for turning a screw to drive the syringe. The syringe pump can include or be operably coupled to a sensor for detecting the position of the syringe. Alternatively, or in combination, the diuretic pump can include other types of pumps and / or actuators. For example, the diuretic pump can include a motor, a gearbox operably coupled thereto, a sensor (e.g., a tachometer or optical encoder) for measuring rotation of the motor, and / or a microcontroller configured to control operation of the motor and monitor the amount of diuretic delivered to patient P. As another example, the diuretic pump may include an electric motor, e.g., a rotary motor, a linear motor, and / or a series of electrically actuated solenoids, configured to advance fluid from the diuretic source 134 toward the patient P through the line 139.
[0032] In some embodiments, the diuretic component 136 includes one or more diuretic sensors configured to determine the amount and / or rate of diuretic flowing toward the patient P. The one or more diuretic sensors may include, for example, a flow sensor, a weight sensor, and / or other sensor types configured to determine the amount and / or rate of diuretic delivered from the diuretic source 134. Optionally, the diuretic sensor may measure diuretic delivery based on output from the diuretic pump, for example, by monitoring the pumping speed (e.g., diuretic pump revolutions per minute, plunger position, etc.). The diuretic component 136 may include additional functional components, for example, an air bubble detector, a pressure sensor, an extravasation sensor (e.g., an ivWatch device), and / or other embedded electronics, for providing feedback signals to the controller 140 to ensure accurate diuretic infusion and / or monitor infusion status.
[0033] The controller 140 is configured to automatically control the infusion of hydration fluid and / or diuretic agent to facilitate safe and effective diuresis of the patient P (e.g., based at least in part on the patient's urination). The controller 140 may include one or more processors and tangible, non-transitory memory configured to store programmable instructions. The controller 140 is operably coupled to the urinary system 110, the hydration system 120, and / or the diuretic system 130 and can receive data (e.g., sensor data) from and send data (e.g., control signals) to different components of these systems. For example, the controller 140 can receive sensor data (e.g., from the sensor 114) from the urinary system 110 to determine and / or monitor the patient's urination. Based on the urination, the controller 140 can determine an appropriate amount and / or rate of diuretic administration to administer to the patient P and can cause the diuretic system 130 to deliver the diuretic accordingly. For example, controller 140 can determine the pumping rate of the diuretic pump to generate a desired diuretic delivery profile. Similarly, controller 140 can determine an appropriate hydration fluid infusion rate for patient P (e.g., based on urine output and / or diuretic administration rate) and cause hydration system 120 to deliver an appropriate amount and / or rate of hydration fluid. For example, controller 140 can determine the pumping rate for hydration fluid pump 126 to achieve a desired hydration fluid infusion rate. Controller 140 can adjust the diuretic administration rate and / or hydration fluid infusion rate based on an appropriate treatment plan protocol, for example, prescribed by a physician and / or managed by controller 140.
[0034] During a procedure, the controller 140 may receive sensor data from different sensors in the urinary system 110, the hydration system 120, and / or the diuretic system 130 to monitor urine output, hydration fluid infusion rate, and / or diuretic administration rate, respectively. The controller 140 may receive sensor data from additional sensors configured to monitor the patient status and / or the operational status of the system 100, such as fluid pressure sensors, blood pressure sensors, air bubble detectors, and analyte detectors. For example, the controller 140 may be operably coupled to at least one sensor implanted in, attached to, or otherwise associated with the body of the patient P. The sensors can provide data regarding any of the patient parameters, i.e., pressure levels (e.g., pulmonary artery pressure, left atrial pressure), bioelectrical measurements (e.g., bioimpedance vector analysis (BIVA)), hemoglobin measurements (e.g., noninvasive hemoglobin measurements), urinary oxygen saturation levels, urine composition (e.g., creatine, sodium, potassium, chloride, etc.), urine temperature, body temperature (e.g., bladder temperature), oral fluid intake, heart rate, heart rate variability, blood oxygenation, hematocrit, hemodynamic data, and any other data described herein. The controller 140 can use data from any of the sensors described herein to monitor treatment progress (e.g., whether treatment is completed), patient status (e.g., whether the patient is responding well or poorly to treatment), and / or potential safety concerns (e.g., whether diuresis is overly aggressive, whether the patient is experiencing side effects), and / or adjust the hydration fluid infusion rate and / or diuretic administration rate based on the sensor data. Additionally, the sensor data can provide feedback to the controller 140 to confirm or verify the effectiveness of the fluid therapy.
[0035] Controller 140 can use other data, such as settings for system 100, user inputs, data indicative of a desired treatment regimen (e.g., a programmed diuretic and / or hydration fluid delivery profile over time), and / or other data collected or calculated by controller 140, to monitor and / or control therapy. In some embodiments, the data used by controller 140 includes current and / or historical data about patient P, such as the diuretic dose delivered to patient P, the volume or rate of urine output, the amount of hydration fluid infused into patient P's body, patient P's weight or changes thereto at different times during the diuretic infusion, indicators of the patient's renal function (e.g., estimated glomerular filtration rate (eGFR)), and / or the time patient P has been treated by system 100. Additionally or alternatively, the data used by controller 140 can include historical data about one or more other patients, as described elsewhere herein.
[0036] Display 150 (e.g., a touch screen, a monitor, etc.) may include a user interface configured to accept input from a user and display output to the user. In some embodiments, display 150 is operably coupled to controller 140, and thus may be used to accept user input indicating treatment parameters, such as parameters related to urination, hydration fluid infusion, and / or diuretic administration. Treatment parameters may include, for example, desired fluid balance level (e.g., positive, negative, or neutral fluid balance), estimated excess fluid volume, target fluid removal volume (e.g., minimum and / or maximum amount of fluid to be removed), desired urination level (e.g., total urination volume, maximum, minimum, and / or average target urination rate), treatment duration (e.g., maximum and / or minimum duration of treatment procedure, planned duration of input balance level and / or urination level), type of hydration fluid, hydration fluid infusion rate (e.g., maximum, minimum, and / or average infusion rate), hydration fluid infusion profile (e.g., a function indicating how the amount and / or rate of hydration fluid infusion is changed over time), hydration These may include time limits for fluid infusion (e.g., maximum and / or minimum duration for hydration fluid infusion), type of diuretic, diuretic dosage (e.g., maximum and / or minimum dosage), diuretic administration rate (e.g., maximum, minimum, and / or average administration rate), diuretic administration profile (e.g., a function indicating how the diuretic dosage and / or administration rate is varied over time), time limits for diuretic delivery (e.g., maximum and / or minimum duration for diuretic delivery), other fluids to be received by the patient during the procedure (e.g., volume of ingested fluids, volume of fluids from other medicinal agents other than the diuretic and / or hydration fluid), and / or suitable combinations thereof.The display 150 can accept other patient-related inputs, including, for example, the patient's gender, weight (e.g., "dry" weight), age, ethnicity, clinical status (e.g., renal function parameters, electrolyte levels such as serum chloride and / or urinary sodium levels), medical history (e.g., outcomes of previous fluid removal procedures, previous fluid therapy responses, etc.), diagnosis (e.g., ADHF, CHF), medications (e.g., whether the patient is diuretic-naive or diuretic-resistant), dietary factors (e.g., whether the patient is on a high-salt or low-salt diet, oral fluid intake), etc.
[0037] Alternatively, or in combination, user input through display 150 can prompt controller 140 to retrieve therapy parameters (e.g., maximum diuretic dose, maximum continuous diuretic dose, and minimum desired urine rate) from tables and / or other data sources. The data sources can be stored within system 100 (e.g., in memory associated with controller 140) and / or can be stored on a separate device (e.g., a remote computing device). In some embodiments, controller 140 retrieves data from a remote database and / or server over a communications network (e.g., a wired network, a wireless network, a cloud-based network, the Internet, and / or any combination thereof). In such embodiments, controller 140 can be operably coupled to a communications device and / or interface configured to transmit and receive data over the communications network.
[0038] Controller 140 can output therapy parameters to the user via display 150 for review and / or feedback. For example, display 150 can show recommended therapy parameters for patient P, such as diuretic, diuretic administration rate recommendations (e.g., initial, maximum, and / or minimum administration rates), hydration fluid infusion rate recommendations (e.g., initial, maximum, and / or minimum infusion rates), urine output rate recommendations (e.g., maximum and / or minimum excretion rates), therapy duration recommendations (e.g., maximum duration of diuretic and / or hydration fluid infusion, maximum total therapy duration), therapy augmentation recommendations (e.g., thiazides, temporary increase in fluid compatibility, additional loop diuretics), and therapy termination recommendations. As another example, display 150 can output one or more predefined therapy programs so the user can select an appropriate program for a particular patient P. Optionally, the user can modify any of the displayed therapy parameters as needed.
[0039] During a treatment procedure, the controller 140 can output information regarding the procedure status to the user through the display 150. For example, the controller 140 may display information regarding any of the following: urination (e.g., current urination rate and / or volume, urination rate and / or volume over time, total urination volume to date), hydration fluid infusion (e.g., current infusion rate and / or volume, infusion rate and / or volume over time, total hydration fluid infused to date), diuretic delivery (e.g., current administration rate and / or volume, administration rate and / or volume over time, total diuretic delivered to date), fluid fit (e.g., current fluid fit, fluid fit over time, net fluid removal to date), system status (e.g., amount of hydration fluid remaining in the fluid source 122, amount of diuretic remaining in the diuretic source 134, remaining reservoir volume in the container 112), therapy time (e.g., therapy start time, predicted and / or planned therapy end time, total therapy duration to date), and notifications (e.g., warnings, alerts, messages, recommendations, predictions, error messages), etc. The user can review the displayed information and provide inputs that instruct the controller 140 to adjust, pause, and / or stop the treatment procedure as appropriate.
[0040] In some embodiments, system 100 includes redundancy in urine system 110, hydration system 120, and / or diuretic system 130 to reduce or minimize interruptions in therapy due to, for example, exhausting urine collection volume, exhausting hydration fluid, and / or exhausting diuretic. For example, system 100 may include redundant components (e.g., container 112, fluid source 122, and / or diuretic source 134) that may be housed in predetermined locations (e.g., on or within console 105 or another portion of system 100). Controller 140 may be configured to detect the presence of redundant components and may automatically or semi-automatically switch between these components so that the therapy procedure can continue uninterrupted or substantially uninterrupted. Alternatively or in combination, system 100 may adjust the timing of user alerts regarding urine collection volume, hydration fluid level, and / or diuretic level based on the availability of redundant components. For example, if a redundant component is available, the system 100 can automatically switch to using the redundant component, or can issue a warning at a later point in time (e.g., closer in time to when the container 112 is believed to be full, the fluid source 122 is believed to be empty, and / or the diuretic source 134 is believed to be empty) so that this switch can be performed quickly using redundant components pre-installed locally in the system 100 without the user having to locate a replacement elsewhere.
[0041] The lack of interruptions in fluid therapy can help ensure the effectiveness of fluid therapy, for example, by alleviating a patient's fluid overload condition as quickly and safely as possible. In some embodiments, even brief interruptions in diuretic delivery and / or hydration fluid infusion can significantly affect a patient's urination (e.g., slowing urination rate), thereby impeding therapeutic efficacy and prolonging treatment time. In some embodiments of the treatment procedures described herein, the concerns discussed above regarding backup supplies of diuretic and / or hydration fluid are believed to be unique to the present technology due to, for example, the relatively large amounts of diuretic and / or hydration fluid utilized over extended periods of time. That is, whereas conventional systems and methods may utilize only a single diuretic source and / or a single hydration fluid source because they administer only relatively small amounts of diuretic and / or hydration fluid, the present technology can ensure continuity of treatment by benefiting from multiple diuretic and / or hydration fluid sources. Similarly, the treatment procedure of the present technology may produce a larger urination volume and / or a higher urination rate in the patient P compared to conventional procedures, and therefore multiple containers 112 may be advantageous in reducing the number of times a user must empty and / or replace containers 112 during the procedure.
[0042] For example, in some embodiments, the urinary system 110 includes two or more redundant containers 112 to ensure that fluid therapy does not have to be stopped or interrupted due to a container 112 being full. In such embodiments, the urinary system 110 may include a flow control assembly 116 (e.g., valves and / or other flow control components) operably coupled to the controller 140 and configured to selectively direct urine from the patient P to one or more of the containers 112. The flow control assembly 116 may initially direct urine received from the patient P to a first container 112. Upon detecting or determining (e.g., based on sensor data from the sensor 114) that the first container is full or nearly full, the flow control assembly 116 may redirect urine received from the patient P to a second container 112. While urine is being directed to the second container 112, a user may empty the first container 112 or replace the first container 112 with an empty container 112. The flow control assembly 116 and / or controller 140 can issue a warning to the user indicating that the first container is full and needs to be replaced or emptied. This process can be repeated to prevent inadvertent interruptions in fluid management therapy due to a full container 112 and / or the inability of the urinary system 110 to accept urine output. In some embodiments, the treatment protocols described herein result in relatively large and / or rapid urination volumes (e.g., compared to conventional therapy), and therefore automatic switching between multiple urine containers is advantageous to minimize interruptions in therapy.
[0043] As another example, hydration system 120 may include multiple redundant hydration fluid sources 122, e.g., to ensure that hydration fluid infusion can continue uninterrupted throughout a clinical session and / or to provide an additional time window for switching hydration fluid sources 122 without interrupting hydration fluid infusion. In such an embodiment, hydration system 120 may include a hydration control assembly (e.g., valves and / or other flow control components, not shown) operably coupled to controller 140 and configured to switch the hydration fluid source from a first fluid source 122 to a second fluid source 122. In such an embodiment, the hydration control assembly may initially deliver hydration fluid from first fluid source 122 to patient P. The hydration control assembly may monitor whether first fluid source 122 is empty or nearly empty, for example, based on data from fluid sensor 128 and / or other sensors associated with hydration system 120. Upon detecting or determining that the first fluid source 122 is empty or nearly empty (e.g., the amount of hydration fluid remaining is less than a predetermined threshold), the hydration control assembly can switch to delivering hydration fluid from the second source 122. This switching process can be repeated to prevent inadvertent interruptions in fluid therapy due to an empty fluid source 122 and / or an inability of the hydration system 120 to provide hydration fluid.
[0044] The process of switching hydration fluid sources 122 can be performed automatically, semi-automatically, or manually. In some embodiments, semi-automatic or manual switching between first and second fluid sources 122 can be advantageous to ensure that hydration system 120 does not automatically inject hydration fluid without user confirmation. In such embodiments, hydration control assembly and / or controller 140 can output a warning asking the user whether they would like to switch hydration fluid from first to second fluid source 122. Upon switching to second fluid source 122, controller 140 can issue a warning to the user indicating that first fluid source 122 is empty and needs to be replaced. Optionally, hydration control assembly and / or controller 140 can implement a pre-authorization procedure that allows the user to allow hydration system 120 to automatically inject a specified volume of additional hydration fluid. Once that volume has been delivered to patient P, the user can be required to provide re-authorization before additional automatic hydration fluid injection.
[0045] In some embodiments, the different fluid sources 122 of the hydration system 120 each provide the same type of hydration fluid. However, in other embodiments, some or all of the fluid sources 122 may provide different types of hydration fluid. The hydration fluids may differ from one another with respect to tonicity, composition, electrolyte content, etc. Depending on the patient's response to diuresis, the hydration system 120 may deliver multiple different hydration fluids to the patient P, either sequentially or simultaneously. For example, if the patient's urination indicates that the patient P has an electrolyte imbalance (e.g., a positive sodium balance), the hydration system 120 may switch to delivering a hydration fluid believed to address this imbalance (e.g., a hydration fluid with a lower sodium content). This switching may be performed using any of the techniques and / or devices described above. That is, the particular fluid or fluids delivered to the patient P may be tailored to the patient's particular clinical condition and / or response to treatment.
[0046] In yet another example, the diuretic system 130 may include multiple redundant diuretic sources 134, e.g., to ensure that diuretic delivery can continue uninterrupted throughout a medical session and / or to provide an additional time window for switching diuretic sources 134 without interrupting diuretic delivery. For example, if a first diuretic source 134 (e.g., a first syringe or container) is depleted, diuretic may continue to be supplied (e.g., substantially without interruption) by a second diuretic source 134 (e.g., a second syringe or container). The second diuretic source 134 may be connected to the console 105 and may further be operably coupled to a sensor (e.g., a location sensor, an optical sensor, a weight sensor, etc.) configured to detect the presence of the second diuretic source 134. That is, the diuretic system 130 can switch to the second diuretic source 134 when the first diuretic source 134 is empty or nearly empty and the second diuretic source 134 is present.
[0047] In some embodiments, diuretic system 130 includes two independent diuretic pumps, each containing its own diuretic source 134. For example, diuretic system 130 may include multiple syringe pumps, each fluidly coupled to its own diuretic-filled syringe. In some cases, such syringes can only be filled by a pharmacist or other medical personnel and therefore cannot be easily replaced by a user (e.g., in less than a few hours). When diuretic system 130 and / or controller 140 detect that first diuretic source 134 is empty or nearly empty (e.g., below a predetermined threshold), it may switch (e.g., automatically or manually) the diuretic supply to second diuretic source 134. This switching process may include stopping the first syringe pump fluidly coupled to the first syringe and starting the second syringe pump fluidly coupled to the second syringe. In other embodiments, the diuretic system 130 includes a single diuretic pump (e.g., a syringe pump) connected to the diuretic source 134. In such embodiments, switching between the first diuretic source 134 and the second diuretic source 134 can include switching the diuretic pump using a diuretic control assembly (e.g., valves and / or other flow control components) from delivering diuretic from the first diuretic source 134 to delivering diuretic from the second diuretic source 134. This switching process can be repeated to prevent inadvertent interruptions in fluid therapy due to an empty diuretic source 134 and / or the inability of the diuretic system 130 to deliver diuretic.
[0048] The process of switching diuretic sources 134 can be performed automatically, semi-automatically, or manually. In some embodiments, manual or semi-automatic switching between the first diuretic source 134 and the second diuretic source 134 can be advantageous to ensure that the diuretic system 130 does not automatically infuse large amounts of diuretic without user confirmation. In such embodiments, the controller 140 can output a warning asking the user a question confirming whether it is appropriate to switch diuretic from the first diuretic source 134 to the second diuretic source 134. When switching to the second diuretic source 134, the controller 140 can issue a warning to the user indicating that the first diuretic source 134 is empty and needs to be replaced. Optionally, the controller 140 can predict the point and / or time range when the first diuretic source 134 will be depleted (e.g., based on the diuretic administration rate) and output a notification so that the user can order or otherwise provide a replacement diuretic source 134 before the first diuretic source 134 is depleted. Additionally, the diuretic control assembly and / or controller 140 can implement a pre-authorization procedure that allows the user to allow the diuretic system 130 to automatically deliver a specified additional dose of diuretic. Once that dose has been delivered to the patient P, the user may be required to provide re-authorization before additional automatic diuretic delivery.
[0049] In some embodiments, the different diuretic sources 134 of the diuretic system 130 each provide the same type of diuretic. However, in other embodiments, some or all of the diuretic sources 134 may provide different types of diuretics. Depending on the patient's response to diuresis, the diuretic system 130 may deliver multiple different diuretics to the patient P, sequentially or simultaneously. For example, the diuretic system 130 may initially deliver a first diuretic to the patient P from a first diuretic source 134. If the patient P does not respond well to the first diuretic (e.g., urination rate does not increase or increases only very slowly), the diuretic system 130 may switch to delivering a second, different diuretic from a second diuretic source 134. The diuretic system 130 can continue to deliver the first diuretic simultaneously with the second diuretic, or can cease delivery of the first diuretic when the second diuretic is delivered. This switching can be performed using any of the techniques and / or devices described above. As another example, the diuretic system 130 can simultaneously administer multiple diuretics to the patient P if the patient P does not respond well to a single diuretic. The ratio of the different diuretics can be varied as needed to elicit an appropriate urination rate. However, in other embodiments, rather than automatically administering an additional diuretic, the diuretic system 130 can output a notification recommending that the user manually administer a different diuretic to the patient P and / or requesting the user approve the administration of a different diuretic that is deemed beneficial with respect to patient safety.
[0050] The system 100 shown in FIG. 1 can be configured in many different ways. For example, the locations of different components of the system 100 can be changed; for example, the urinary system 110, hydration system 120, and / or diuretic system 130 can reside in different locations within the console 105. As another example, any one of the urinary system 110, hydration system 120, or diuretic system 130 can be part of a separate system or device (e.g., a separate console) or can be omitted entirely. For example, in some embodiments, the urinary system 110 is replaced with a mechanism for monitoring a patient's urination without the need for a catheter 118 and / or urine collection, such as an ultrasound sensor that measures the patient's bladder volume. The ultrasound sensor can be implemented as a patch or similar device that is coupled to the patient's body. The controller 140 can process the ultrasound sensor data to detect changes in bladder volume and can determine the corresponding amount and / or rate of urination based on this bladder volume. The use of a non-invasive urine monitoring mechanism, such as an ultrasound sensor, can enable the treatment procedures described herein to be performed in an outpatient setting.
[0051] As another example, in some embodiments, hydration system 120 is omitted, and thus diuresis is performed without hydration fluid infusion or hydration fluid is manually infused. Diuresis with hydration fluid infusion may be more advantageous for patients with low serum chloride levels (e.g., patients on a low-salt diet), whereas patients with high serum chloride levels (e.g., patients on a high-salt diet) may be able to tolerate diuresis with little or no hydration fluid infusion. Optionally, the hydration fluid infusion rate may be altered based at least in part on the patient's serum chloride level; for example, a smaller amount and / or slower rate of hydration fluid infusion may be used when the patient's serum chloride level is high (e.g., greater than or equal to 105 mmol / L).
[0052] In yet another example, diuretic system 130 may be omitted, and thus diuresis is not performed or is performed manually. In such an embodiment, system 100 may provide automatic fluid exchange via hydration system 120 and / or automatically monitor the patient's urination via urinary system 110, but the diuretic may be administered manually by a medical professional according to techniques known to those skilled in the art.
[0053] System 100 may optionally include or be used in combination with additional systems or devices, such as systems or devices configured to perform any of the following functions: administering other drugs and / or medications other than diuretics and hydration fluids (e.g., heart failure medications), monitoring other patient parameters other than urination (e.g., blood pressure, weight, heart rate, blood oxygen saturation, respiratory rate, temperature), and / or performing other types of medical procedures (e.g., dialysis, ultrafiltration) on patient P simultaneously or sequentially with the fluid removal procedure.
[0054] FIG. 2 is a flow diagram of a method 200 of treating a patient according to embodiments of the present technology. In some embodiments, method 200 is used to treat a patient for fluid overload by removing fluid from the patient to create a negative fluid balance (net fluid loss). Method 200 may be performed by any of the embodiments of the systems and devices described herein, such as system 100 of FIG. 1. In some embodiments, some or all of the blocks of method 200 are performed by a system or device including one or more processors and a memory storing instructions that, when executed by the processor, cause the system or device to perform one or more of the blocks described herein. For example, method 200 may be performed by controller 140 of system 100 of FIG. 1 and / or another suitable processor. Optionally, some or all of the blocks of method 200 may be performed automatically or semi-automatically with little or no human intervention.
[0055] Method 200 may begin at block 202 by obtaining a urination rate from a patient. The urination rate may be obtained from a urine monitor and / or urine collection system connected to the patient, such as urinary system 110 of FIG. 1. The system may determine the urination rate based on received input data, such as data from one or more sensors (e.g., sensor 114 of FIG. 1). As described above, the sensors may be configured to measure the urination rate based on flow rate, weight (e.g., of container 112 of FIG. 1), volume, fluid level, and / or any other suitable parameters. The urination rate may be calculated based on the received input, for example, by a controller (e.g., controller 140 of FIG. 1) operably coupled to the sensor. The urination rate may be a current rate or an average rate measured over a predetermined period of time (e.g., the last 5 or 10 minutes). The urination rate may be updated continuously or repeatedly (e.g., every 30 seconds, every minute, every 2 minutes, etc.). In some embodiments, the steps of block 202 are performed simultaneously with some or all of the other blocks of method 200 (e.g., blocks 204, 206, and / or 208) to enable continuous or substantially continuous urination monitoring throughout method 200.
[0056] At block 204, the method 200 optionally continues by providing the patient with a diuretic at an administration rate. The diuretic may be or include furosemide, bumetanide, ethacrynic acid, torsemide, combinations thereof, and / or other diuretics known in the art. In some embodiments, the diuretic is delivered as part of a solution that includes saline or other hydration fluid mixed therewith. The diuretic may be administered automatically or semi-automatically by a diuretic system connected to the patient, such as diuretic system 130 of FIG. 1. The diuretic system may be operably coupled to a controller (e.g., controller 140 of FIG. 1) to trigger diuretic delivery according to a planned and / or preprogrammed therapy regimen.
[0057] In some embodiments, the treatment protocol includes multiple phases, each associated with a different delivery profile for the diuretic. In such embodiments, block 204 can be performed as part of an initial phase (also known as a "dose determination phase") that determines an appropriate diuretic administration rate for treating the patient. During the dose determination phase, the diuretic is injected at an initial administration rate, and then the administration rate can be gradually increased (e.g., "ramped") to elicit an increase in the patient's urination rate. The diuretic administration rate can be increased according to a desired function or delivery profile, such as a continuous function, a block-like function, or a combination thereof. This function can include iteratively increasing the administration rate linearly, exponentially, according to a polynomial function, and / or any other suitable ramp function or profile. In some embodiments, the diuretic is delivered such that subsequent administration rates exceed the most recent administration rate by a predetermined percentage (e.g., at least 5%, 10%, 15%, 25%, etc.). The predetermined percentage can be increased or decreased over time depending, for example, on the desired fluid therapy and / or patient requirements. Optionally, the diuretic can be administered in a manner that doubles the diuretic administration rate or total diuretic dose over a range of periods (e.g., 10 minutes, 15 minutes, 20 minutes, or a range of 10-20 minutes). However, in other embodiments, the dosage determination phase can include one or more periods during which the diuretic administration rate does not increase and / or remains substantially constant. The dosage determination phase can continue until the patient's urination achieves or exceeds a desired threshold rate and / or a predetermined period of time has elapsed, at which point the diuretic administration rate can be adjusted as described below in block 208.
[0058] In block 206, the method 200 can optionally include providing a hydration fluid to the patient at a hydration rate. The hydration fluid can include saline and / or other sodium-containing fluids and can be administered automatically or semi-automatically by a hydration fluid system connected to the patient, such as hydration system 120 of FIG. 1 . The hydration fluid can be administered before, during, and / or after providing a diuretic in block 204 (e.g., before, during, and / or after a titration phase). Intravenous infusion of a hydration fluid containing electrolytes (e.g., sodium and / or chloride) can increase diuretic efficiency, which is counterintuitive since the goal of fluid therapy is net fluid removal. The hydration fluid can reduce or prevent intravascular depletion, reduced cardiac output, and / or reduced renal perfusion, among other benefits.
[0059] In some embodiments, hydration fluid is provided to a patient based at least in part on a corresponding urination rate, e.g., to facilitate net fluid loss from the patient. For example, the hydration rate can be lower than the urination rate. In some embodiments, the hydration rate is a percentage of the urination rate (e.g., 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, or 10% of the urination rate) over a given range of urination rates (e.g., 0 mL / hr to 1000 mL / hr). Optionally, this percentage can be higher over certain portions of this range (e.g., over the lower end of the range to reduce the likelihood of hypotension) and / or lower over other portions of this range (e.g., over the upper end of the range to increase net fluid loss). As another example, the hydration rate can be substantially matched to the urination rate (e.g., 100% of the urination rate) over an initial urination volume by the patient (e.g., at least the initial 150 ml, 200 ml, or 250 ml), and / or over an initial period (e.g., the first 1, 2, or 3 hours), and / or over an initial period during hydration fluid and / or diuretic dosage titration, and / or until the patient's urination rate achieves a predetermined threshold. Thereafter, the hydration rate can be adjusted to be lower than the urination rate. In yet another example, the hydration rate can be determined based on whether the urination rate is higher or lower than one or more different thresholds, where the difference between the urination rate and the hydration fluid rate increases as the urination rate increases. In such an embodiment, the difference between the urination rate and the hydration fluid rate can increase as the urination rate increases (where the urine rate is higher than the hydration fluid rate), and thus the net fluid loss from the patient can increase as the urination rate increases.
[0060] In block 208, method 200 can include adjusting at least one of the administration rate of the diuretic or the hydration rate of the hydration fluid, thereby causing fluid loss from the patient. For example, (i) the diuretic administration rate can be adjusted, (ii) the hydration rate can be adjusted, or (iii) both the diuretic administration rate and the hydration rate can be adjusted. In some embodiments, the diuretic administration rate is adjusted after the dosage determination phase of the treatment procedure is completed. As discussed above in block 204, the dosage determination phase can end (i) when a predetermined amount of time has elapsed since the initial diuretic administration and / or (ii) when the urination rate is greater than, equal to, or becomes greater than a predetermined threshold rate. The treatment procedure can then switch to a phase (also known as a “continuous delivery phase” or a “fluid reduction phase”) in which the diuretic administration rate is adjusted to an administration rate configured to maintain the patient's urination rate at or above a desired elimination rate to cause net fluid loss.
[0061] The adjusted diuretic administration rate can be the initial administration rate for the fluid reduction phase and can be determined in many different ways. For example, the adjusted diuretic administration rate can be based on the results of the dosage determination phase (e.g., the administration rate at which the patient's urination achieves or exceeds a target threshold). In exemplary embodiments, the diuretic administration rate is reduced, for example, to maintain the patient's urination rate at a predetermined rate and / or within a predetermined range (e.g., not to exceed a 5%, 10%, or 20% change from the predetermined rate). Reducing the diuretic administration rate can reduce the rate of increase in urination rate (e.g., to cause the patient to urinate at or near a constant or substantially constant rate), but can also be reduced without actually reducing the urination rate itself.
[0062] In some embodiments, the adjusted diuretic administration rate is a predetermined percentage of the current administration rate (e.g., the administration rate at the end of the dose-sizing phase) or a predetermined fraction or a predetermined percentage of the cumulative diuretic dose (e.g., the cumulative dose delivered during the dose-sizing phase). For example, the administration adjustment rate can be a predetermined percentage (e.g., 10%, 15%, 20%, 25%, 30%, or a range of 10-30%) of the total diuretic dose delivered to the patient at that time. For example, if the total dose delivered is 100 mg and the predetermined percentage is 25%, the administration adjustment rate can be 25 mg / hr. In some embodiments, the percentage used to calculate the adjusted diuretic administration rate is based on the pharmacokinetic properties of the particular diuretic being infused. For example, for furosemide, this percentage may be 20% so that if 50 mg of furosemide is infused within 60 minutes, the adjusted diuretic administration rate may be 10 mg / hr.
[0063] In some embodiments, block 208 includes delivering diuretic at the adjusted diuretic administration rate until the fluid reduction phase is complete, e.g., until a predetermined period of time has elapsed, and / or until the patient's urination drops below a lower micturition threshold, and / or until a target net fluid loss volume is achieved. During the fluid reduction phase, the diuretic administration rate can be constant or substantially constant (with no more than a 5%, 10%, or 20% change from the initially determined adjusted diuretic administration rate). However, in other embodiments, block 208 can include making additional adjustments to the diuretic administration rate during the treatment procedure (e.g., increasing and / or decreasing the diuretic administration rate). These adjustments can be based on whether one or more of a set of predetermined conditions are met, such as whether the urination rate is excessively high (e.g., which may indicate that the patient has high and / or increasing serum diuretic levels). This set of conditions can include (i) the average urine rate being higher than a predetermined rate over a period of time, (ii) the average rate of change in urine rate being higher than a predetermined rate, and / or (iii) the diuretic administration rate being higher than a predetermined administration rate. If some (e.g., two) or all of these conditions are met, the diuretic administration rate can be reduced (e.g., by a predetermined amount or a predetermined percentage), also referred to herein as "down-titrating."
[0064] In some embodiments, downward titration is performed only when all or most of the above conditions are met, thereby avoiding unnecessary reductions in the diuretic administration rate and thus avoiding unnecessary interruptions in the treatment procedure due to the urination rate remaining high. For example, while other methods may interrupt fluid therapy and reduce the diuretic administration rate (e.g., to zero mg / hr) if the urination rate is even slightly exceeded, the process described herein can reduce the administration rate (e.g., to a non-zero or zero administration rate) only when one or more factors are met, such as when the urination rate is high and continues to increase. In other words, the process described herein can prevent unnecessary reductions in the diuretic administration rate when the urination rate is temporarily high (e.g., higher than a predetermined rate) but trending downward. This method can prevent or reduce excessive diuresis, excessive fluid loss, and / or electrolyte loss, and further limit the patient's unnecessary exposure to additional diuretic. In addition to this, the diuretic administration rate can be titrated downward rather than stopping the diuretic completely, so that fluid therapy can continue (albeit at a lower voiding rate) without having to completely restart the procedure.
[0065] As another example, the additional adjustment made to the diuretic administration rate in block 208 can include increasing the diuretic administration rate, which is also referred to herein as "re-ramping" or "up-titrating." In some embodiments, re-ramping is determined based on a set of conditions and is performed if the urination rate is excessively low. This set of conditions can include (i) the average urine rate being lower than a predetermined threshold rate for a predetermined period of time, and / or (ii) a deficit greater than a predetermined amount accumulating over this predetermined period of time. The "deficit" can be defined on a plot as the area between the urination rate and a set rate (e.g., 325 mL / hr) and can represent how much and for how long the urination rate has fallen below the set rate. If some or all of these conditions are met, re-ramping can be performed by gradually increasing the diuretic administration rate until (i) a predetermined amount of time has elapsed and / or (ii) the urination rate is greater than or equal to the predetermined threshold rate. The re-ramping step can be the same as or substantially similar to the dose determination step described above in block 204. In an exemplary embodiment, the dose rate or "ramp" can begin at any dose identified during the dose determination step, e.g., the current dose rate, the previously determined dose rate, or another suitable dose rate (e.g., not the one at which the dose began).
[0066] The re-ramping process can be performed automatically, semi-automatically, or manually. In some embodiments, re-ramping is a semi-automatic or manual process that requires user approval, e.g., for regulatory and / or safety reasons. In such embodiments, the system can output a notification to the user (e.g., via display 150 of FIG. 1 ) instructing the user to confirm that re-ramping is being initiated. Optionally, the system can perform a pre-approval procedure that allows the user to allow the system to automatically perform re-ramping under certain conditions (e.g., within a specific time period until a predetermined urination volume and / or urination rate is achieved, such as with respect to a maximum diuretic dose and / or a maximum diuretic administration rate). This approach can enable automatic re-ramping under limited circumstances, which can reduce the amount of human involvement during the treatment procedure and improve the responsiveness of the system to the patient's current condition. Once the pre-approval condition has elapsed, the user may be required to provide re-approval before additional automatic re-ramping is permitted.
[0067] In some embodiments, block 208 further includes adjusting the diuretic administration rate in response to potential and / or detected obstructions within the urine collection system (e.g., air blockage, kinks in the fluid lines, etc.). For example, an air blockage may be any partial or complete obstruction of fluid flow due to gas (e.g., air) trapped within the fluid system. An air blockage may cause an unnatural drop in urination rate, which may affect diuretic administration rate determinations (e.g., resulting in an excessively high diuretic administration rate). In some embodiments, the presence of an air blockage is detected based on a period of little or no urination (due to the air blockage obstructing urine flow) followed by a sudden, large bolus of urination (due to built-up pressure in the fluid lines that clears the air blockage). Upon detecting that an air blockage or other obstruction was or is present, the system can compensate by adjusting the diuretic administration rate to the administration rate that would have been used if the air blockage or other obstruction had not occurred. The appropriate administration rate can be determined based on historical data for the patient receiving fluid therapy and / or one or more other patients (e.g., the diuretic administration rate before the air blockage occurred, the diuretic administration rate calculated from the patient's urination rate before the air blockage occurred, etc.).
[0068] Alternatively or in combination, block 208 may include adjusting the hydration rate by, for example, increasing or decreasing the hydration rate based on the patient's urination rate to facilitate net fluid loss from the patient. For example, as described above, the hydration rate may initially be matched to the patient's urination rate for a set of initial conditions (e.g., a predetermined time period, initial urination volume, and / or initial urination rate). Once the initial conditions have passed, the hydration rate may be maintained at a rate lower than the urination rate (e.g., a percentage of the urination rate), so that the patient exhibits net fluid loss during the fluid reduction phase. The hydration rate may be determined in different ways, such as as a percentage or fraction of the patient's urination rate based on whether the urination rate is higher or lower than some different threshold (e.g., the difference between the urination rate and the hydration rate increases as the urination rate increases) and / or any other suitable method.
[0069] Optionally, the diuretic administration rate and / or hydration rate can be adjusted based on factors other than the patient's urination rate. For example, in addition to or instead of the urination rate, the diuretic administration rate and / or hydration rate can be adjusted based on any one or any combination of the patient's urine conductivity, urine sodium concentration, urine temperature, urine oxygen level, etc. In some embodiments, the diuretic administration rate and / or hydration rate can be adjusted based on the patient's blood pressure to avoid putting the patient in a hypotensive state. In some embodiments, if the patient's blood pressure level is too low (e.g., below a certain threshold or threshold range), the system can avoid increasing the diuretic administration rate and / or reduce the diuretic administration rate for a predetermined period of time. Alternatively or in combination, the system can increase the hydration rate for a predetermined period of time if a low blood pressure level is detected (e.g., up to a maximum allowable hydration rate and / or to provide a desired fluid exchange profile (e.g., 100% balance with the patient's urination rate)). The system can output a warning indicating that the patient's blood pressure level is low, allowing the user to check the patient's status. Optionally, the system can take into account both blood pressure levels and urination rates, for example, the system can issue an alert if the patient's blood pressure is low and the patient's urination rate drops, and / or adjust the diuretic administration rate and / or hydration rate. This approach can improve patient safety and control of the treatment procedure.
[0070] In some embodiments, some or all of the blocks of method 200 are performed as part of a medical procedure to treat a patient for a fluid overload condition. Method 200 can be used as a primary, standalone therapy to treat fluid overload, or in combination with other therapies (e.g., as a post-primary therapy to reduce the likelihood of hospital readmission). Method 200 can be performed in any suitable setting, such as an inpatient setting or an outpatient setting. In embodiments in which method 200 is performed as an outpatient procedure, the overall duration of method 200 can be reduced (e.g., to 10 hours, 5 hours, 4 hours, 3 hours, 2 hours, or 1 hour or less).
[0071] Method 200 shown in FIG. 2 can be modified in many different ways. For example, any of the blocks of method 200, such as block 204 or 206, can be excluded. In some embodiments, block 204 is excluded, such that method 200 controls hydration fluid infusion but not diuretic delivery, or does not include any diuretic delivery at all. Similarly, block 206 can be excluded, such that method 200 controls diuretic delivery but not hydration fluid infusion, or does not include any hydration fluid infusion at all. As another example, some or all of the blocks of method 200 (e.g., any of blocks 202, 204, 206, and / or 208) can be performed in a different order and / or repeated. In yet another example, method 200 can optionally include additional blocks not shown in FIG. 2 (e.g., triggering delivery of additional medications, obtaining parameters other than urination rate, etc.).
[0072] The present technology can provide many advantages with respect to treating fluid overload and / or managing a patient's fluid levels. For example, embodiments of the present technology have been shown to consistently reduce a patient's fluid volume more quickly, safely, and efficiently than conventional treatment systems and therapies. For example, while conventional methods may typically require at least five days to remove a net fluid volume of 4-5 L, embodiments of the present technology have been shown to remove a net fluid volume of 4-5 L within 24 hours. In addition, embodiments of the present technology have also been shown to remove significant amounts of salt from patients through hypernatremia. This salt removal can reduce the likelihood of a patient reaccumulating fluid after discharge, which may lead to reduced readmission rates. Furthermore, embodiments of the present technology can automatically and continuously monitor urination, hydration fluid infusion, and / or diuretic delivery during treatment procedures to mitigate patient safety concerns (e.g., excessive diuresis and / or hypotension).
[0073] Embodiments of the present technology can provide various benefits, such as: (i) optimizing net fluid volume removal and / or net sodium removal; (ii) reducing the time required to produce a desired net fluid removal by allowing physicians to use higher diuretic doses and / or administration rates earlier in treatment compared to conventional treatments; (iii) avoiding or reducing the risk of adverse events such as excessive diuresis, dehydration, acute kidney injury, and / or intravascular depletion; (iv) quickly assessing whether a patient has diuretic resistance; and (v) providing treatment data recording. Embodiments of the present technology can achieve an average net fluid removal rate (e.g., average urination rate minus average hydration fluid infusion rate) of at least 225 mL / hr, enabling a net fluid volume removal of 3.4 L per day based on oral or IV infusion of 2 L of fluid per day. This rate of fluid removal while replacing sodium can shorten overall hospital stay and / or enable improved decongestant relief.
[0074] Various aspects of one or more embodiments of the present technology may be based, at least in part, on one or more models (“models”), such as artificial intelligence (AI) models and / or machine learning (ML) models. Each of these models may be trained using historical treatment data from one or more other patients and configured to determine and / or predict information about the patient receiving treatment and / or otherwise inform system and / or user decisions regarding the patient's therapy. For example, in some embodiments, a model is configured to determine and / or predict information about diuretic delivery during fluid therapy. Each of these models may be configured to (i) predict a diuretic dosage that will elicit a desired urinary response from the patient, (ii) predict the occurrence of a therapy re-ramp and / or automatically re-ramp the patient's therapy, and / or (iii) identify and / or select a diuretic most likely to elicit a desired fluid removal response. Additionally or alternatively, a model may be configured to determine and / or predict information about hydration fluid delivery during fluid therapy. For example, the model can be configured to (i) predict the patient's risk of being able to tolerate / not tolerate a given hydration fluid delivery rate, (ii) predict the likelihood that the patient's urination will be above a threshold (e.g., reducing it below the threshold), and / or (iii) adjust the patient's hydration fluid delivery rate to improve the patient's urination. In these and other embodiments, the model can be configured to determine and / or predict information regarding modifying the patient's fluid therapy, one or more phases, blocks, and / or protocols therefor. For example, the model can be configured to (i) determine information regarding the decision to discontinue a patient's fluid therapy and provide guidance to a user regarding such discontinuation, (ii) predict the patient's risk of readmission after the patient's fluid therapy has been terminated, (iii) recommend and / or determine oral diuretic dosage information for the patient, and / or (iv) identify patients who are not expected to respond to fluid therapy.In additional embodiments, one or more of the models are configured to determine the likelihood that the patient will experience one or more adverse events during fluid therapy before and / or during the initiation of fluid therapy. In some embodiments, the model is configured to determine an expected time until the hydration fluid source and / or the diuretic source will be empty and / or an expected time until the urine collection container will be full.
[0075] Generally, the model is expected to improve the effectiveness of the fluid therapy phases / blocks / protocols described herein. In some embodiments, the model is expected to improve a particular patient's response to the fluid therapy phases / blocks / protocols described herein. In additional embodiments, the model is expected to optimize (e.g., maximize) the patient's response to the fluid therapy phases / blocks / protocols described herein in real time, for example, based on data received from the patient regarding the patient's response to the fluid therapy.
[0076] II. URINE CHARACTERIZATION ACQUISITION AND RELATED SYSTEMS, DEVICES, AND
[0077] 3 is a partial schematic diagram of a urine flow cartridge 301 configured in accordance with an embodiment of the present technology. The urine flow cartridge 301 may also be referred to as a "cartridge 301," a "urine cartridge 301," a "flow cartridge 301," a "sensing cartridge 301," an "integrated cartridge 301," and a "flow cell 301." At least some aspects of the cartridge 301 may be substantially similar or identical in structure and / or function to the cartridge 101 of FIG. 1.
[0078] The cartridge 301 can define a flow channel 302. The flow channel 302 can include a fluid inlet 304 and a fluid outlet 306. The fluid inlet 304 can be fluidly coupled to or otherwise configured to receive fluid (e.g., urine) from a patient, for example, via the fluid line 119. The fluid outlet 306 can be fluidly coupled to a collection container 112 and / or another suitable fluid outlet location (e.g., a waste fluid collector). In the embodiment shown in FIG. 3 , the cartridge 301 includes a single flow channel 302 having one inlet 304 and one outlet 306, although in other embodiments, the cartridge 302 can include more (e.g., at least two, three, four, etc.) flow channels 301 and / or each of the flow channels 302 can have its own inlet 304 and / or outlet 306 or can share the inlet 304 and / or outlet 306 with one or more other flow paths. Upon operation, fluid (e.g., urine) entering cartridge 301 through fluid inlet 304 can flow through all or a portion of flow channel 302 toward fluid outlet 306, exit through fluid outlet 306, and / or flow into container 112.
[0079] Cartridge 301 may further include one or more sensors 314 (individually shown as first sensor 314a, second sensor 314b, third sensor 314c, fourth sensor 314d, and nth sensor 314n) positioned at different locations along flow channel 302. Each of sensors 314 may be at least generally similar or identical in structure and / or function to sensor 114 of FIG. Each of the sensors 314 may include one or more respective sensing elements 316 (individually shown as a first sensing element 316a of the first sensor 314a, a second sensing element 316b of the second sensor 314b, a third sensing element 316c of the third sensor 314c, a fourth sensing element 316d of the fourth sensor 314d, and an nth sensing element 316n of the nth sensor 314n) configured to detect one or more characteristics (e.g., excretion rate / flow rate, temperature, conductivity, concentration, partial pressure of oxygen, etc.) of a fluid (e.g., urine) flowing through the flow channel 302. Each of the sensing elements 316 may be positioned at least partially within the flow channel 302, disposed about at least a portion outside the flow channel 302, and / or otherwise configured to detect one or more characteristics of a fluid flowing through the flow channel 302. In at least some embodiments, for example, sensor 314 includes one or more conductivity sensors, temperature sensors, oxygen sensors, flow sensors, etc. In these and other embodiments, sensing element 316 includes one or more conductive contacts, one or more thermistors, one or more light sources (e.g., LEDs, infrared light sources), etc. Each of sensing element 316 and sensor 314 can be communicatively coupled to controller 140 such that readings from sensing element 316 and sensor 314 can be communicated to controller 140 for analyzing, monitoring, and / or otherwise obtaining characteristics of the fluid. The obtained characteristics can be used to start, stop, or adjust fluid therapy for the patient as described herein.
[0080] In operation, urine contacts one or more of the sensing elements 316 as it exits the fluid line 119 and travels through the flow channel 302 from the inlet 304 toward the outlet 306 until it reaches the container 112. In some embodiments, the first sensor 314a is a conductivity sensor, the second sensor 314b is a temperature sensor, and the third sensor 314c is an oxygen sensor. In such embodiments, the first sensor 314a may include two electrodes spaced apart from one another. The sensors 314 are operably coupled to the controller 140, such that signals from the sensors 316 are communicated to the controller 140 and used to adjust fluid therapy for the patient. The controller 140 may process the received signals to obtain, for example, a first derivative (e.g., rate of change), a second derivative (e.g., change in rate of change), etc. As described herein, adjustments to fluid therapy may include adjusting (e.g., increasing or decreasing) one or both of the diuretic administration rate and the hydration fluid infusion rate.
[0081] FIG. 4 is a partial schematic diagram of a cartridge 401 configured in accordance with an embodiment of the present technology. At least some aspects of the cartridge 401 can be at least generally similar or identical in structure and / or function to the cartridge 101 of FIG. 1 and / or the cartridge 301 of FIG. 3. For example, the cartridge 401 defines a fluid channel 402 having a fluid inlet 404 fluidly coupled to a patient, e.g., through a fluid line 119, and a fluid outlet 406 fluidly coupled to a container 112 and / or another fluid outlet location. The cartridge 401 further includes a fluid (e.g., urine) conductivity sensor 414 and a fluid (e.g., urine) temperature sensor 418. The conductivity sensor 414 can include a pair of conductive contacts 416 a and 416 b spaced apart from each other along the fluid channel 402 for obtaining the conductivity of a fluid flowing therebetween. The pair of conductive contacts 416 a, 416 b can be non-contacting or positioned within the fluid channel 402. In non-contact embodiments, one of the pair of conductive contacts 416a, 416b can generate an electric field that induces a current in the other. Changes to the type, composition, etc. of the fluid in the fluid channel 402 can change one or more aspects (e.g., amplitude, voltage, etc.) of the induced current, and this change in the induced current can be used to determine one or more properties (e.g., conductivity, resistance, etc.) of the fluid in the fluid channel 402. A temperature sensor 418 can be positioned between (e.g., equidistant from) the pair of conductive contacts 416a, 416b. Conductivity changes with temperature; therefore, positioning the temperature sensor 418 between the pair of conductive contacts 416a, 416b allows the temperature sensor 418 to detect a temperature that is approximately or substantially the average of the temperatures of the fluid at or near each of these conductive contacts 416a, 416b. In some embodiments, the temperature sensor 418 is positioned upstream or downstream of the pair of conductive contacts 416a, 416b.However, by disposing the temperature sensor 418 between a pair of conductive contacts 416 a, 416 b, the conductive contacts 416 a, 416 b can be spaced apart to reduce measurement variability therefrom, while also reducing (or even minimizing) the size of the cartridge 401 compared to, for example, embodiments in which the temperature sensor 418 is positioned upstream or downstream of the conductive contacts 416 a, 416 b. The controller 140 can adjust the conductivity data based at least in part on the temperature data from the temperature sensor 418. In at least some embodiments, the controller 140 can determine an estimated sodium content and / or a sodium content indication of the patient's urine based at least in part on the temperature data from the temperature sensor 418 and the conductivity data from the conductivity sensor 414.
[0082] Fluid line 119, or a portion thereof, can have an outer diameter (OD) that is larger than its inner diameter (ID). For example, fluid line 119 can have an OD of at least 0.25 inches and / or an ID of at least 0.125 inches. In some embodiments, fluid line 119 is thinner than other (e.g., conventional) fluid lines, for example, to provide more accurate readings of urine characteristics described herein.
[0083] Figure 5A is a perspective view of another urine collection system 500 ("system 500") configured in accordance with embodiments of the present technology. System 500 may include at least some aspects that are substantially similar or identical in structure and / or function to one or more of the embodiments described herein (e.g., system 100 of Figure 1), such as one or more of the components for monitoring and / or managing fluid levels described above with reference to Figure 1. Additionally or alternatively, any of the features of the embodiments of Figures 5A and 5B may be combined with each other and / or with any of the other systems and devices described herein (e.g., system 100 of Figure 1).
[0084] 5A, system 500 includes a urine collection and monitoring system 502 ("urine system 502"), an automatic hydration fluid injection system 504 ("hydration system 504"), an automatic diuretic injection system 506 ("diuretic system 506"), a controller or control system 508 ("controller 508"), and a display or input / output unit 510 ("display 510"). Controller 508 may be operatively coupled to each of urine system 502, hydration system 504, diuretic system 506, and / or display 510. System 500 may further include a console or structure 505 ("console 505") that incorporates, houses, and / or otherwise supports all or a portion of urine system 502, hydration system 504, diuretic system 506, controller 508, and / or display 510. Similar to the embodiments described above, the urinary system 502 collects and monitors urine from the patient, whereupon the automatic hydration fluid infusion system 504 automatically delivers fluid to the patient and / or the automatic diuretic infusion system 506 automatically delivers diuretic to the patient based in part on data obtained from the urinary system 502. For example, as described herein, the amount of diuretic and / or hydration fluid administered to the patient is based on urine output from the patient, the patient's urine conductivity, and / or the patient's urine oxygen content measured by the urinary system 502.
[0085] FIG. 5B is a partial schematic perspective view of a urinary system 502. The urinary system 502 can include a urinary cartridge 501 and a urinary flow assembly 560. The urinary cartridge 501 and the urinary flow assembly 560 may be referred to together herein as the flow control assembly 516. The urinary flow assembly 560 can include a container mounting component 532 (“mounting component 532”). In the illustrated embodiment, the mounting component 532 includes a coupler (e.g., a hook) that allows for hanging or supporting a container 512 (e.g., the urine bag or container 112 of FIG. 1 ). The mounting component 532 is movable between a first, unstressed position and a second, stressed position when it is supporting the weight of the container 512. Thus, when in the second position or when not in the first position, the mounting component 532 can indicate the presence of the container 512 therein. When in the second position, the attachment component 532 can engage components of the urine flow assembly 560, for example, by activating one or more sensors, to monitor and / or determine the patient's urination rate.
[0086] The urine cartridge 501 can be detachably coupled to the urine flow assembly 560. For example, the urine flow assembly 560 can include one or more receiving features 509 (indicated by reference numerals 509a and 509b) configured to receive the urine cartridge 501. In the illustrated embodiment, the urine flow assembly 560 includes a pivot receiving feature 509a and a slot receiving feature 509b, which, together, can couple the urine cartridge 501 to the urine flow assembly 560. The pivot receiving feature 509a can pivotally engage with the urine cartridge 501 such that the urine cartridge 501 can pivot toward and / or at least partially enter the slot receiving feature 509b to engage (e.g., operably engage) the urine flow assembly 560. The urine cartridge 501 can be coupled to a proximal fluid line 519′ configured to receive urine and / or other fluids from the patient P and a distal fluid line 519 configured to direct urine to the container 512. When coupled to the urine flow assembly 560, the urine cartridge 501 can position and orient the distal fluid line 519 relative to aspects of the urine flow assembly 560 to enable urine flow measurements and provide urination (e.g., average urination rate). In some embodiments, the distal fluid line 519 is coupled (e.g., glued) to the urine cartridge 501 prior to attachment to the console 505 at the receiving feature 509. Additional details regarding the engagement between the urine cartridge 501 and the receiving feature 509 are described in U.S. Patent No. 11,633,137, filed June 8, 2022, the entire contents of which are incorporated herein by reference. In some embodiments, the proximal fluid line 519′ can be coupled to the container 512 (rather than to the patient P as shown in FIG. 5B ), and the distal fluid line 519 can be coupled to the patient P (rather than to the container 512 as shown in FIG. 5B ).In such an embodiment, the urine cartridge 501 may operate as described herein, e.g., direct urine flow from the patient P to the container 512, but flow through at least the portion of the fluid line 519 engaged with the urine flow assembly 560 may be in the opposite (downward) direction.
[0087] 5C is a partial, schematic, perspective, cross-sectional view of the system 502. Fluid F (e.g., urine) from the patient P can flow through a portion of the urine flow assembly 560, through a distal fluid line 519 (FIG. 5B), and into the container 512. The urine flow assembly 560 can include one or more fluid sensors 562 operable to measure and / or determine the flow of fluid F through the urinary system 502. In the illustrated embodiment, the urine flow assembly 560 includes a first fluid sensor 562a and a second fluid sensor 562b. The first fluid sensor 562a can include a load cell and, when coupled to the mounting component 532, can be configured to measure or generate (e.g., continuously) first sensor data including the weight of the container 512. The first sensor data (e.g., the weight of the container 512 and / or a change therein) can be used to generate a first patient urination output (e.g., an average volumetric flow rate). The second sensor 562b may include a flow sensor and may be configured to measure or generate (e.g., continuously) second sensor data indicative of the flow of fluid F through the fluid line. The second sensor data may be used to generate a second patient output (e.g., an average volumetric flow rate).
[0088] The second sensor 562b can include a groove 537 (e.g., a U-shaped groove) that at least partially defines a slot or channel 539 that receives a portion of the distal fluid line 519. Additionally, the slot 539 is oppositely defined by a portion of the urine cartridge 501 when coupled to the urine flow assembly 560. Further, with reference to FIG. 5B , when the urine cartridge 501 is coupled to the system 502 and / or console 505 ( FIG. 5B ), the urine cartridge 501 and flow sensor 562b can position and / or orient the fluid line 519 within the slot 539 to ensure accurate and reliable flow measurements. In the illustrated embodiment, for example, the urine cartridge 501 can be configured to press and / or hold a portion of the distal fluid line 519 against the flow sensor 562b, thereby improving the accuracy of urination measured by the flow sensor 562b. In other words, if the distal fluid line 519 is not properly positioned in the slot 539 or if the length of the distal fluid line 519 extending from the urine cartridge 501 to the container 512 is improper (e.g., too short), flow measurements by the flow sensor 562b may be less accurate and / or less consistent between measurements. For example, if the distal fluid line 519 extending from the urine cartridge 501 to the container 512 is too short, the container 512 may impose extra stress on the urine cartridge and / or cause the urine cartridge to physically fall out, which may affect the flow measurements by the flow sensor 562b. Furthermore, if the distal fluid line 519 extending from the urine cartridge 501 to the container 512 is too short, the container 512 may be pulled by the distal fluid line 519, which may alter the weight reading of the container 512 by the first sensor 562a and result in an inaccurate measurement of the flow rate or volume of fluid entering the container 512.
[0089] Referring again to FIG. 5C , the urinary system 502 can further include one or more flow control devices 564. The flow control device 564 can include a pinch clamp or valve configured to fully or at least partially regulate fluid flow through the system 502, such as when priming one or more of the fluid lines. The flow control device 564 can be used to regulate flow when the system 502 determines, for example, that the weight of the container 512 is decreasing based on first sensor data from the first sensor 562a. In such an embodiment, the flow control device 546 can regulate flow only when the second sensor 562b is disabled or deactivated and only the first sensor 562a is activated. While the flow control device 564 is closed and there is no flow to the container 512, the patient's urination is not measured. However, in such an embodiment, the urination rate and / or urination volume can be calculated or estimated based at least on the period of no flow and flow measurements obtained after flow resumes. In some embodiments, pinch clamp 564 is configured to block flow when distal fluid line 519 (FIG. 5B) and / or proximal fluid line 519′ (FIG. 5B) are primed. Priming fluid lines 519, 519′ can remove any air within these lines and / or otherwise create a solid (or at least nearly solid) column of fluid within the lines. This solid column of fluid means that as soon as the patient voids urine into their bladder, or a volume of fluid is immediately visible in container 512 as an increase in weight / volume / etc. Pinch clamp 564 can block flow through these lines to prevent, or at least partially prevent, air from entering the primed fluid lines, such as when fluid lines 519, 519′ are separated from cartridge 501. Additional details regarding priming of fluid lines are described in U.S. Pat. No. 11,633,137, filed June 8, 2022, the entire contents of which are incorporated herein by reference. The flow control device 564 can regulate fluid flow without contacting the fluid by externally pinching the fluid line.Alternatively, flow control device 546 can be a gate, needle, or other type of valve that can regulate fluid flow by coming into contact with the fluid. In the illustrated embodiment, flow control device 564 is positioned upstream of flow sensor 562b. In other embodiments, flow control device 564 can be located downstream of flow sensor 562b and / or have any other suitable location.
[0090] FIG. 5D is a perspective view of the urine cartridge 501. The urine cartridge 501 can include a body 566 having (i) a first or upper end portion 566a, (ii) an opposite second or lower end portion 566b, and (iii) a handle 561 residing at least partially between the first end portion 566a and the second end portion 566b. The first end portion 566a can include a first urine system coupling feature 568a (“first coupling feature 568a”), and the second end portion 566b can include a second urine system coupling feature 568b (“second coupling feature 568b”). The first coupling feature 568a and the second coupling feature 568b can be configured to releasably engage the urine flow assembly 560 to ensure precise positioning of the fluid line 519 relative to the flow sensor 562b (FIG. 5C). In the illustrated embodiment, for example, first mating feature 568a may be pivotally received by pivot-receiving feature 509a (FIG. 5A), and second mating feature 568b may be inserted into a correspondingly shaped recess (not shown) in console 505 (FIGS. 5A and 5B). Second mating feature 568b may include one or more tabs having a flared end or other shape configured to matingly engage one or more correspondingly shaped recesses or slots in console 505.
[0091] The urine cartridge 501 can further include a sensor assembly 570, one or more urine line coupling features 565, and / or one or more urine line return features 567. The sensor assembly 570, the one or more urine line coupling features 565, and the one or more urine line return features 567 can receive or otherwise direct fluid F to flow from the patient P to the container 512. Thus, the sensor assembly 570, the one or more urine line coupling features 565, and / or the one or more urine line return features 567 can together define a path for fluid to flow from the patient P to the container 512.
[0092] The sensor assembly 570 can be coupled to the body 566 of the urine cartridge 501 such that the sensor assembly 570 can be operably coupled to the controller 540 (e.g., controller 140 of FIG. 1 ) of the system 500 when the urine cartridge 501 is received in the slot-receiving feature 509b ( FIG. 5B ). The sensor assembly 570 can be configured to receive fluid from the patient P, for example, through the proximal fluid line 519′. The sensor assembly 570 can be oriented so that fluid from the patient flows through the sensor assembly 570 in a vertical and / or upward first direction F1 shown in FIG. 5D or in another upward direction plus or minus 1 degree, 5 degrees, 10 degrees, 15 degrees, 20 degrees, or 30 degrees therebetween. Orienting the sensor assembly 570 in this manner is expected to reduce or even prevent air blockages and / or other bubble formation within the sensor assembly 570 and / or its associated tubing. For example, because gas (e.g., air) has a higher buoyancy than liquid (e.g., urine, water, etc.), directing fluid flow upward through sensor assembly 570 allows the natural buoyancy of the gas to urge any gas within sensor assembly 570 and / or its associated tubing in the same direction as the upward fluid flow. This provides any gas within sensor assembly 570 and / or its associated tubing to tend to flow with or faster than the fluid, reducing the likelihood of the gas forming any bubbles or air blockages that could reduce or stop fluid flow and / or cause erroneous or inaccurate readings from sensor assembly 570.
[0093] The one or more urine line coupling features 565 can be configured to position the first or upstream portion 519a of the fluid line 519 relative to the urine flow assembly 560 (FIGS. 5B and 5C), described earlier in this specification with reference to at least FIGS. 5B and 5C. The upstream portion of the fluid line 519 can direct fluid flow in a first direction F1. In the illustrated embodiment, the first urine line coupling feature 565a can include an aperture or opening extending through the first coupling feature 568a, and the second urine line coupling feature 565b includes a fork-shaped connector or a pinch connector. In other embodiments, one or more of the urine line coupling features 565 can have other configurations suitable for enabling the upstream portion 519a of the fluid line 519 to be positioned relative to the urine flow assembly 560 (FIGS. 5B and 5C). In these and / or other embodiments, the fluid line 519 may be joined or otherwise attached (eg, with an adhesive) to the urine cartridge at one or more of the coupling features 565 .
[0094] The one or more urine line return features 567 can be configured to engage a second or downstream portion 519b of the fluid line 519 to facilitate returning the fluid line 519 to the container 512, such as when the container 512 is suspended from the mounting component 532 (e.g., below the urine cartridge 501). The downstream portion 519b of the fluid line 519 can direct fluid flow in a second direction F2 that is different (e.g., opposite) from the first direction F1, or in another downward direction within a range of plus or minus 1 degree, 5 degrees, 10 degrees, 15 degrees, 20 degrees, or 30 degrees therebetween. In the illustrated embodiment, the first urine line return feature 567a includes a channel extending through at least a portion of the handle 561, with an opening or ring anchor 567b disposed in the second end portion 566b. The channel 567a can be defined at least in part by the removable section 561a of the handle 561. The removable section 561a can be removed from the remainder of the body 566 to allow the fluid line 519 to be positioned within the channel 567a.
[0095] In some embodiments, the urine cartridge 501 includes a fluid line engagement feature 563 (“engagement feature 563”) that can at least partially define a slot 539 ( FIG. 5C ) when the urine cartridge 501 is coupled to the console 505. The engagement feature 563 can be positioned and / or otherwise configured to operably engage or abut the fluid line 519 along with the urine flow assembly 560. As described above (e.g., with reference to FIG. 5C ), the urine cartridge 501 can position and / or orient the fluid line 519 within the slot 539 to ensure accurate and consistent flow measurements. In the illustrated embodiment, the engagement feature 563 includes a protrusion or tab extending from the body 566 to urge or otherwise operably engage the distal fluid line 519 into the slot 539 when the urine cartridge 501 is coupled to the console 505 and / or to limit bending, bending, or other undesirable orientation of the distal fluid line 519. In other embodiments, the engagement feature 563 may include a series of protrusions or tabs, or may have another structure configured to operably position the distal fluid line 519 relative to the console 505 when the urine cartridge 501 is coupled to the console 505.
[0096] FIG. 5E is a partially exploded perspective view of the urine cartridge 501. For clarity of illustration, the distal and proximal fluid lines 519, 519′ (FIG. 5D) have been omitted. The removable section 561a of the handle 561 can be separated from the remainder of the body 566 to allow a user to access the channel 567a and, for example, position a portion of the distal fluid line 519 (FIG. 5D) within the channel 567a. The body 566 can define a receiving area 569 configured to releasably receive the sensor assembly 570.
[0097] 5F is a partially exploded view of sensor assembly 570. Sensor assembly 570 can include a sensor assembly housing 572, a cover plate 574, one or more first fasteners 576, one or more second fasteners 578, and a sensor board 580. Sensor assembly housing 572 can define an interior 573, one or more sensing openings 575 (individually identified as first, second, and third sensing openings 575a-575c, respectively), and a fluid conduit 577. Interior 573 can be configured to receive sensor board 580. Fluid conduit 577 can be disposed along distal fluid path 519 and configured to receive a flow of fluid (e.g., urine) from a patient, for example. Thus, urine and / or other fluids from the patient can flow through the fluid conduit 577 and the upstream and downstream portions 519a, 519b of the distal fluid line 519 (FIG. 5D) into the container 512 (FIG. 5D). One or more sensing apertures 575 can define respective openings into the fluid conduit 577. When the sensor board 580 is disposed in the interior 573, different sensing elements of the sensor board 580 can be positioned at least partially within the fluid conduit 577 through the sensing apertures 575 or otherwise operatively positioned relative to the fluid conduit 577 to obtain one or more properties of the fluid in the fluid conduit 577. In at least some embodiments, for example, one or more sensors carried by the sensor board 580 can be non-contacting, minimizing or eliminating one or more sensing apertures.
[0098] The one or more first fasteners 576 can be configured to couple the sensor board 580 to the sensor assembly housing 572 at the interior 573. As such, the one or more first fasteners 576 can at least partially prevent the sensor board 580 from moving relative to the one or more sensing openings 575. The one or more first fasteners 576 can include screws (as shown in the embodiment illustrated in FIG. 5F ), pins, rivets, adhesive, and / or other suitable fasteners. In some embodiments, the one or more first fasteners 576 can be omitted, and the sensor assembly housing 572 and / or sensor board 580 can be configured to be coupled to one another by an interference fit, correspondingly shaped tabs and tab-receiving features configured to matingly engage one another, or the like.
[0099] The cover plate 574 may be coupled to the sensor assembly housing 572 by one or more second fasteners 578 to cover or seal the interior 573. The one or more second fasteners 578 may include screws (as shown in the embodiment depicted in FIG. 5F ), pins, rivets, adhesives, ultrasonic welding, and / or other suitable fasteners or fastening techniques. In some embodiments, the one or more second fasteners 578 may be omitted, and the sensor assembly housing 572 and / or cover plate 574 may be configured to be coupled to one another by an interference fit, correspondingly shaped tabs and tab-receiving features configured to matingly engage one another, or the like.
[0100] 5G and 5H are top and bottom perspective views, respectively, of a sensor board 580. The sensor board 580 can include a body 582, a fluid (e.g., urine) conductivity sensor 514, a fluid (e.g., urine) temperature sensor 518, one or more connectors 584, and one or more interconnectors 586. The conductivity sensor 514 can include a pair of conductive contacts 588a and 588b spaced apart from each other for acquiring the conductivity of a fluid flowing therebetween (FIG. 5H). The pair of conductive contacts 588a, 588b can be non-contacting and positioned within a fluid conduit 577 (FIG. 5F) and / or otherwise configured to acquire one or more properties from the fluid within the fluid conduit 577 as described herein above. The pair of conductive contacts 588a, 588b can include gold contacts, carbon contacts, and / or other suitable conductive contacts. Gold electrodes are less likely to develop biofilms than carbon electrodes, but carbon electrodes may be suitable for potential operation over longer periods (e.g., more than 1 day, 2 days, 3 days, 4 days, 1 week, 2 weeks, etc.). One or more sealing elements 590 (e.g., O-rings, adhesives, etc.) can be disposed at least partially around the contacts 588a, 588b. The sealing elements 590 can seal one or more of the sensing openings 575 (FIG. 5F). The temperature sensor 518 can be positioned approximately adjacent to the pair of conductive contacts 588a, 588b. For example, the temperature sensor 518 can be positioned upstream, downstream, between one or both of the pair of conductive contacts 588a, 588b, and / or at a location within the range of 6 inches, 5 inches, 4 inches, 3 inches, 2 inches, 1 inch, 0.75 inches, 0.5 inches, 0.25 inches, 0.1 inches, 0.01 inches, or another suitable distance. The temperature sensor 518 may include a glass bead thermistor and / or one or more other suitable temperature sensors. In some embodiments, one or more sealing elements may be disposed at least partially around the temperature sensor 518. In other embodiments, an adhesive (e.g., a UV-curable adhesive) and / or other suitable material may be used to form a substantially fluid-tight seal between the temperature sensor 518 and its corresponding sensing opening 575.The temperature sensor 518 may have a tight fit within the corresponding sensing opening 575 that prevents or at least partially prevents adhesive and / or other sealing elements from migrating into the fluid conduit 577 .
[0101] The distance (e.g., center-to-center distance) between the conductive contacts 588a and 588b can affect the accuracy of the conductivity measurement, with longer distances providing more potentially accurate measurements. In the illustrated embodiment, the distance (e.g., center-to-center distance) between the conductive contacts 588a and 588b is 0.44 inches, which can enable the sensor assembly 570 to provide accurate measurements while maintaining a generally compact form factor. In other embodiments, the distance between the conductive contacts 588a and 588b can be greater than 0.44 inches, such as 0.88 inches, 1 inch, or even 2 inches. These longer distances can improve the accuracy of the sensor assembly's measurements and / or reduce signal variation between sensors, but are also expected to increase the size of the sensor assembly 570.
[0102] Conductivity measurements can also vary with temperature; therefore, positioning the temperature sensor 518 between a pair of conductive contacts 516 a, 516 b allows the temperature sensor 518 to detect a temperature that is approximately or substantially the average of the temperatures of the fluid at or near each of the pair of conductive contacts 516 a, 516 b. Similarly, positioning the temperature sensor 518 between a pair of conductive contacts 516 a, 516 b can space the conductive contacts 516 a, 516 b apart to reduce measurement variations therebetween, while also allowing the size of the cartridge 501 to be reduced (or further minimized) compared to, for example, embodiments in which the temperature sensor 518 is positioned upstream or downstream of the conductive contacts 516 a, 516 b. The controller 540 ( FIG. 5D ) can adjust the conductivity data based at least in part on the temperature data from the temperature sensor 518. In at least some embodiments, controller 540 can determine, estimate, and / or indicate the sodium content of the patient's urine based at least in part on the temperature data from temperature sensor 518 and the conductivity data from conductivity sensor 514. Connector 584 can include contact pins or other structures configured to communicatively couple conductivity sensor 514 and / or temperature sensor 518 to controller 540, for example, as shown in FIG. 5D . One or more interconnectors 586 can include wires, traces, etc. configured to operably couple conductivity sensor 514 and / or temperature sensor 518 to connector 584.
[0103] FIG. 5I is a perspective cross-sectional view of the urine cartridge 501. When the sensor assembly 570 is coupled to the urine cartridge, the conductivity sensor 514 and the temperature sensor 518 can be positioned at least partially within the fluid conduit 577, for example, to acquire one or more characteristics of a fluid (e.g., urine) received from a patient. The fluid conduit 577 can have a first end 577a and an opposing second end 577b. As shown in FIG. 5I, the second end 577b can be positioned above the first end 577a. The first end 577a can be coupled to a proximal fluid line 519′ to receive fluid from the patient P. The second end 577b can be coupled to a distal fluid line 519 to direct the fluid to the collection container 512 (FIG. 5B). That is, fluid can (i) enter fluid conduit 577 at first end 577a of fluid conduit 577 through proximal fluid line 519′ and (ii) exit fluid conduit 577 in an upward first direction F1 and into distal fluid line 519 at second end 577b of fluid conduit 577. Fluid conduit 577 can have a first inner diameter D1 that is larger than a second inner diameter D2 of distal fluid line 519 and / or proximal fluid line 519′. In some embodiments, the larger inner diameter D1 allows electric field lines (not shown) to form (e.g., completely form) between conductive contacts of conductivity sensor 514 without interference from the walls of fluid conduit 577. Sealing element 590 can prevent, or at least partially prevent, fluid in conduit 577 from leaking into sensor assembly 570 (e.g., through sensing opening 575).
[0104] 6 is a block diagram illustrating a method 600 for providing an output associated with a patient's fluid therapy based at least in part on the patient's urination (e.g., urination rate) and urinary conductivity in accordance with an embodiment of the present technology. Method 600 is illustrated as a series of steps, acts, processes, process portions, and / or blocks 602-606. At least a portion of blocks 602-606 may be performed by a fluid management system and / or one or more components thereof, such as system 100 and / or controller 140 of FIG. 1 and / or system 500 and / or controller 508 of FIG. 5A.
[0105] At block 602, method 600 includes acquiring (e.g., detecting or determining) urination by the patient. In some embodiments, acquiring urination by the patient includes measuring the patient's urination, for example, through one or more flow rate sensors. The flow rate sensors may be included in a cartridge, such as one or more of cartridges 101, 301, 401, 501 described herein above. Additionally or alternatively, the urination rate may be acquired through one or more sensors configured to detect the amount (e.g., weight, volume, etc.) of urine in the collection container 112 (FIG. 1).
[0106] At block 604, the method 600 includes obtaining the patient's urine conductivity. Urinary conductivity correlates strongly with urine sodium levels and is therefore a good surrogate for urine sodium detection. In addition, measuring conductivity is less expensive and generally easier than directly measuring sodium concentration, e.g., providing a more reliable and / or less noisy signal. Urinary sodium concentration is an important measure of health in heart failure patients receiving fluid therapy. For example, one of the kidney's functions is to alter the sodium content of urine to maintain a steady level of serum sodium. One of the accelerating factors in worsening heart failure is impairment of the patient's natural sodium regulation mechanism. A drop in urine sodium concentration below a predetermined level (e.g., 75 millimoles per liter (“mmol / L”)) may indicate that the kidneys are retaining sodium to maintain serum sodium levels. An increase in urine sodium concentration above a predetermined level (e.g., 100 mmol / L) may indicate that the kidneys are excreting excess sodium to maintain adequate serum sodium levels.
[0107] During fluid therapy, a sodium-containing fluid (e.g., a hydration fluid such as 0.9% saline) may be infused into the patient based at least in part on the patient's urination. If it is determined (e.g., by controller 140 of FIG. 1 ) that the patient's urine sodium concentration is dropping and a normal amount of hydration fluid is being infused, there is a potential risk that the patient may be at risk of developing a positive serum sodium state. Thus, if the urine sodium drops, the fluid therapy system (e.g., controller 140) may suggest and / or automatically adjust therapy to maintain safety and / or prevent harm to the patient. On the other hand, if the patient's urine sodium concentration is high, the fluid therapy system may not make a modification because the patient's kidneys are well-tolerating the therapy. In some embodiments, the hydration fluid infusion rate may be reduced to maximize the net amount of fluid and / or net sodium removed from the patient.
[0108] In some embodiments, obtaining the urine conductivity includes measuring the urine conductivity using one or more conductivity sensors (e.g., sensor 414 in FIG. 4 ). The urine conductivity can be measured continuously or intermittently via the one or more conductivity sensors. The conductivity sensors can be included in a cartridge, such as one or more of cartridges 101, 301, 401, 501 described herein above. In at least some embodiments, one or more of the conductivity sensors and one or more of the flow rate sensors (block 602) are part of the same cartridge. The measured urine conductivity can be used to provide a corresponding urine sodium concentration. For example, controller 140 (FIG. 1) can estimate or determine the patient's urine sodium concentration based at least in part on the urine conductivity measurements.
[0109] In some embodiments, obtaining urine conductivity further includes, for example, determining the temperature of the patient's urine as it flows through the conductivity sensor. As described herein (e.g., with reference to FIG. 4), urine conductivity varies with temperature, and therefore, determining urine temperature can enable temperature-based compensation of the conductivity signal, which is expected to result in more accurate urine conductivity readings.
[0110] In some embodiments, before obtaining urine conductivity, method 600 includes calibrating one or more urine conductivity sensors and / or one or more urine sodium concentration sensors. For example, in some embodiments, a fluid with a known electrolyte content (e.g., a saline solution with a known sodium content) is used to prime and / or flush fluid line 119 and / or any sensors fluidly coupled thereto. Because the fluid has a known electrolyte content, readings from the urine sodium concentration sensors and / or urine conductivity sensors can be calibrated during the flush stage.
[0111] At block 606, method 600 includes providing one or more outputs associated with the fluid therapy the patient is receiving. Typically, the one or more outputs may include, for example, one or more alerts or notifications presented to a user or physician and / or one or more modifications or adjustments to the patient's fluid therapy. One or more of the outputs may be based at least in part on urination (block 602) and / or changes therein, and / or urinary conductivity and / or sodium concentration (block 604) and / or changes therein. For example, if urinary sodium concentration (or an indication thereof) measured indirectly by urinary conductivity drops, the fluid therapy system may suggest one or more modifications to maintain safety and / or prevent harm to the patient. While described below as providing suggestions, those skilled in the art will recognize that in at least some embodiments, as a result of one or more outputs, the system may automatically modify therapy, e.g., by modifying a hydration fluid compatibility level for urination, modifying a diuretic administration rate, etc., as described in the suggestions to adjust or optimize therapy.
[0112] The urine conductivity corresponds to a urine sodium concentration lower than or equal to a low urine sodium concentration threshold (e.g., lower than or equal to 75 mmol / L and / or decreases by at least 5%, 10%, 15%, 20%, 30%, etc. over a predetermined period of time, e.g., at least 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours), and urination is lower than or equal to a low urination threshold (e.g., a urination rate averaged over the past 3 hours lower than 325 mL / hr and / or an insufficiency of the deficit sum function). If the paw has increased by more than 150 mL over the past three hours and / or decreased by at least 5%, 10%, 15%, 20%, 30%, etc. over a predetermined period of time, such as at least 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours, etc., the one or more outputs can include a warning that the patient's urine sodium concentration is low and / or falling, a prompt to actively monitor urine sodium, serum sodium, and / or the patient's other electrolytes, and / or a prompt to modify or stop therapy. Additionally or alternatively, the warning can include one or more suggested therapy modifications, such as a change to be made (e.g., an increase) in the hydration fluid infusion rate, an adaptation of the ratio or percentage of infused saline to urine output, and / or a change to be made (e.g., an increase) in the diuretic infusion rate.
[0113] In one example, during block 606, the system may adjust the hydration fluid balance percentage assuming a high urine sodium level (e.g., 135 mmol / L) so that the amount of infused sodium in the infused hydration fluid matches the displayed amount of sodium that would be infused using the standard algorithm for the same sodium excretion. For example, using 135 mmol / L urine sodium as a normalizing value, if a patient excretes 1,050 mL of urine with a measured, estimated, or calculated urine sodium concentration of 67.5 mmol / L, the corresponding urine volume for a urine with a sodium content of 135 mmol / L is 525 mL (i.e., 1050 mL). *(67.5 / 135=525). In this embodiment, the volume of saline substituted for 525 mL of "normalized" urine is 250 mL of normal saline; therefore, to achieve equivalent sodium balance, 1,050 mL of urine having a sodium concentration of 67.5 mmol / L would be substituted with the same 250 mL of normal saline. While it is contemplated that for urine sodium levels greater than 135 mmol / L, substitution with a fluid containing a higher level of sodium may be used, in other embodiments, for example, such substitution may be omitted or performed less frequently to maximize net sodium removal.
[0114] If the urine sodium concentration reading is below or equal to the low urine sodium concentration threshold and urination is equal to or higher than the high urination threshold (e.g., urination averaged over the past three hours is greater than 625 mL / hr and / or has increased by at least 5%, 10%, 15%, 20%, 30%, etc. over a predetermined period of time, such as at least 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours), one or more outputs can include a warning that the patient's urine sodium concentration is high and / or increasing, a prompt to actively monitor urine sodium, serum sodium, and / or the patient's other electrolytes, and / or a prompt to modify or stop therapy. For example, a prompt to modify therapy can include a prompt to reduce saline adequacy, reduce hydration fluid infusion rate, and / or increase diuretic administration rate.
[0115] If the urine sodium concentration reading is less than or equal to the low urine sodium concentration threshold and urination is between the low urination threshold (e.g., at 325 mL / hr) and the high urination threshold (e.g., at 625 mL / hr), one or more outputs may include a warning that the patient's urine sodium concentration is within an acceptable range, a prompt to actively monitor urine sodium, serum sodium, and / or the patient's other electrolytes, and / or a prompt to continue therapy and / or a suggestion that no therapy modification is necessary at this time.
[0116] On the other hand, if the urine sodium concentration reading is high, it suggests that the patient's kidneys are tolerating the therapy well. More specifically, if the urine sodium concentration reading is equal to or higher than a high urine sodium concentration threshold (e.g., greater than or equal to 100 mmol / L and / or increases by at least 5%, 10%, 15%, 20%, 30%, etc. over a predetermined period of time, e.g., at least 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours), and urination is less than or equal to a low urination threshold (e.g., of 325 mL / hr), one or more outputs may include a prompt to increase the diuretic administration rate, administer additional diuretic, and / or stop the patient's therapy.
[0117] If the urine sodium concentration reading is equal to or higher than a high urine sodium concentration threshold (e.g., of 110 mmol / L) and urination is equal to or higher than a high urination threshold (e.g., of 625 mL / hr), one or more outputs can include, for example, a prompt to reduce hydration fluid compatibility to maximize fluid and / or salt removal from the patient.
[0118] When the urine sodium concentration indication is equal to or higher than a high urine sodium concentration threshold (e.g., of 100 mmol / L) and urination is between a low urination threshold (e.g., of 325 mL / hr) and a high urination threshold (e.g., of 625 mL / hr), the one or more outputs can include a prompt to increase the diuretic administration rate and / or augment fluid therapy. In some embodiments, when the urine sodium concentration indication is equal to or higher than a high urine sodium concentration threshold and urination is between a low urination threshold and a high urination threshold, the one or more outputs include a prompt to increase the diuretic administration rate and / or augment fluid therapy only if urination is decreasing.
[0119] 7 is a block diagram illustrating a method 700 for providing an output associated with a patient's fluid therapy based at least in part on the patient's urination (e.g., urination rate) and urinary oxygen content (e.g., partial pressure of oxygen) in accordance with an embodiment of the present technology. Method 700 is illustrated as a series of steps, acts, processes, process portions, and / or blocks 702-706. At least a portion of blocks 702-706 may be performed by a fluid management system and / or one or more components thereof, such as system 100 and / or controller 140 of FIG. 1 and / or system 500 and / or controller 508 of FIG. 5A.
[0120] In block 702, method 700 includes acquiring urination from the patient. In some embodiments, acquiring urination from the patient includes acquiring a urinary flow rate or urination rate from the patient. Block 702 may be at least generally similar to or identical to block 602 of method 600 (FIG. 5).
[0121] At block 704, method 700 includes acquiring the patient's urinary oxygen content. The urinary oxygen content (e.g., urinary oxygen partial pressure) of voided urine can be an important measure of the health of a heart failure patient undergoing decongestant treatment. For example, a high urinary oxygen content can indicate good and / or expected kidney function. A low urinary oxygen content can be a sign of renal hypoxia, which can be an indicator of (i) poor kidney health, (ii) the kidneys may be consuming oxygen to actively conserve fluid, and / or (iii) acute kidney injury (AKI). Continuous measurement of urinary oxygen concentration has the potential to be a much more rapid indicator of kidney health and / or the onset of acute kidney injury than, for example, measuring serum creatinine, the current standard for AKI measurement. Combining urinary oxygen with acquired urination (block 706) can provide even greater diagnostic value. For example, data from a urinary oxygen content sensor can be used to adjust the patient's fluid therapy, for example, if the measured urinary oxygen content falls outside a predetermined range. Urinary oxygen content can be obtained by a device that measures urinary oxygen partial pressure using an optical oxygen sensor that uses dynamic luminescence quenching, such as an optical oxygen sensor manufactured by PreSens Precision Sensing GmbH, headquartered in Regensburg, Germany. In some embodiments, the oxygen sensor can be positioned upstream of the fluid therapy system and / or at least near the patient's bladder, kidneys, and / or catheter. For example, the oxygen sensor can be positioned immediately adjacent to the patient's catheter or at least partially within the patient's bladder. Placing the oxygen sensor at least near (e.g., within 10 cm, 5 cm, 1 cm, 0.1 cm, etc.) the patient's bladder, kidneys, and / or catheter is expected to improve the accuracy of the oxygen sensor measurement. In some embodiments, the tubing used to deliver urine from the patient to the fluid therapy system is permeable to oxygen; therefore, placing the oxygen sensor at least near the patient's bladder, kidneys, and / or catheter can enable the oxygen sensor to obtain a measurement before, or at least substantially before, oxygen can dissipate from the tubing.Placing the urinary oxygen sensor farther away from the patient's bladder, kidneys, and / or catheter is expected to increase the amount of oxygen dissipated through the tubing before it can be measured, particularly for patients with slow urine rates. Urine oxygen content sensors are often supplied unsealed, e.g., exposed to ambient air. Thus, block 704 may include waiting a predetermined amount of time (e.g., at least 5, 10, 15, 30, etc.) to allow the oxygen content sensor to equilibrate with conditions within the system (e.g., the relatively low oxygen content within fluid line 119). In some embodiments, obtaining the urinary oxygen content may include obtaining the temperature of the urine, for example, using temperature sensor 418 ( FIG. 4 ) and / or another temperature sensor. In at least some embodiments, controller 140 may use temperature data from the temperature sensor to compensate for temperature-related effects on the urinary oxygen content data from the urinary oxygen content sensor.
[0122] In some embodiments, obtaining the urine oxygen content (block 704) includes obtaining the patient's blood oxygen saturation level. Generally, interpretation of the urine oxygen sensor reading may vary based at least in part on the patient's blood oxygen saturation level. When the patient has a normal blood oxygen saturation level (e.g., 92-100% saturation), the urine oxygen sensor signal described above may be interpreted as described herein. However, when the patient is in a hypoxic state (e.g., blood oxygen saturation below 92%), the urine oxygen level may also be reduced. Thus, the fluid therapy system (e.g., controller 140) may interpret the urine oxygen content signal using different urine oxygen content ranges based on the patient's blood oxygen saturation level and provide therapy modifications and / or other outputs. The fluid therapy system may adjust therapy based on the patient's overall hypoxemic state.
[0123] In some embodiments, obtaining the urine oxygen content (block 704) includes obtaining the presence or absence of air in the fluid line 119, for example, using an ultrasonic sensor and / or another suitable sensor. For example, a sudden change in urine oxygen content (e.g., greater than 50%, 60%, 70%, 80%, 90%, 100%, etc.) can indicate the presence of air and / or other gases in the fluid line. In such embodiments, fluid therapy can be temporarily interrupted to clear air bubbles from the fluid line 119.
[0124] In some embodiments, method 700 includes calibrating one or more urinary oxygen sensors prior to obtaining the urinary oxygen content. For example, in some embodiments, a fluid with a known oxygen content (e.g., a saline solution with a known or zero oxygen content) is used to prime fluid line 119 and / or to flush fluid line 119 and / or any sensors fluidly coupled thereto. Because the fluid has a known oxygen content, readings from the one or more urinary oxygen sensors can be calibrated during the flush stage.
[0125] At block 706, method 700 includes providing one or more outputs associated with the fluid therapy the patient is receiving. Typically, the one or more outputs may include, for example, an alert or notification presented to a user or physician and / or one or more modifications or adjustments to be made to the patient's fluid flow path. One or more of the outputs may be based at least in part on urine output (block 702) and / or modifications to be made thereto, and / or urine oxygen content (block 704) and / or modifications to be made thereto (e.g., taking into account the patient's blood oxygen saturation level). For example, if urine oxygen content drops, the fluid therapy system may suggest one or more modifications to the patient's fluid therapy to maintain safety and / or prevent harm to the patient. While described below as providing suggestions, those skilled in the art will recognize that in at least some embodiments, as a result of the one or more outputs, the system may automatically modify the therapy by, for example, modifying the hydration fluid compatibility level for urine output, modifying the diuretic administration rate, etc., as described in the suggestions to adjust or optimize the therapy.
[0126] More specifically, if the urine oxygen content is below or equal to a low urine oxygen content threshold (e.g., at most 50 mmHg, 40 mmHg, 30 mmHg, 25 mmHg, 20 mmHg, 10 mmHg, 5 mmHg, and / or decreases by at least 5%, 10%, 15%, 20%, 30%, etc. over a predetermined period of time, such as at least 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours), and urination is below or equal to a low urination threshold (e.g., of 325 mL / hr), one or more outputs can include a prompt to reduce the diuretic administration rate, increase saline adequacy, and / or stop fluid therapy. If this condition persists for a longer period of time without user response, the system could automatically stop therapy.
[0127] If the urine oxygen content is lower than or equal to the low urine oxygen content threshold and urination is equal to or higher than the high urination threshold (e.g., 625 mL / hr), it suggests that the patient may be experiencing the polyuria phase of acute kidney injury. Therefore, increasing the saline adaptability should be considered, and the system could advise the user to increase the saline adaptability or automatically initiate an increase in saline adaptability. If the urine oxygen content is lower than or equal to the low urine oxygen content threshold while the urination rate is decreasing and / or between the high and low urination thresholds, it suggests that the kidneys are at high risk of developing damage. When this condition is detected, the system can suggest to the user or automatically increase the fluid balance to attempt to improve renal function and / or renal perfusion before the kidneys develop significant damage. Thus, one or more outputs can include prompts to reduce the diuretic administration rate, increase the saline adaptability, and / or stop therapy.
[0128] One or more outputs can include a prompt to increase saline adequacy when the urine oxygen content is less than or equal to the low urine oxygen content threshold and urination is between the low urination threshold (e.g., at 325 mL / hr) and the high urination threshold (e.g., at 625 mL / hr).
[0129] If the urine oxygen content is higher than or equal to the high urine oxygen content threshold (e.g., at least 20 mmHg, 25 mmHg, 50 mmHg, 60 mmHg, 40 mmHg, 80 mmHg, 90 mmHg, 100 mmHg, etc., and / or increases by at least 5%, 10%, 15%, 20%, 30%, etc. over a predetermined period of time, e.g., at least 15 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours), and urination is lower than or equal to the low urination threshold (e.g., of 325 mL / hr), it indicates that the kidneys may be able to tolerate an increase in diuretic infusion rate, thereby allowing for the recommendation to "re-ramp" the diuretic infusion or to add a second diuretic if the initial diuretic maximum continuous dose has been reached. Thus, the one or more outputs can include a prompt to increase therapy by, for example, increasing the diuretic delivery rate, administering additional diuretic (e.g., a thiazide), or adjusting (e.g., increasing) hydration fluid compatibility.
[0130] If the urine oxygen content is greater than or equal to the high urine oxygen content threshold and urination is greater than or equal to the high urination threshold (e.g., 625 mL / hr), this suggests that the kidneys may be able to tolerate a reduction in saline infusion rate, thereby increasing net fluid removal and net sodium removal. Thus, one or more outputs can include a prompt to reduce the infusion rate of hydration fluid.
[0131] If the urine oxygen content is greater than or equal to the high urine oxygen content threshold and urination is between the low urination threshold (e.g., at 325 mL / hr) and the high urination threshold (e.g., at 625 mL / hr) and / or has a slope indicating a trend toward the low urination threshold, one or more outputs can include suggestions to "re-ramp" the patient's therapy and / or administer additional diuretic (e.g., if the maximum continuous dose of the first diuretic (e.g., furosemide) has been reached). Thus, the one or more outputs can include prompts to increase the diuretic administration rate, administer a second diuretic, and / or decrease the hydration fluid infusion rate.
[0132] 8 is a block diagram illustrating a method 800 for providing an output associated with a patient's fluid therapy based at least in part on the patient's urine conductivity and urine oxygen content (e.g., urine oxygen partial pressure) in accordance with an embodiment of the present technology. Method 800 is illustrated as a series of steps, acts, processes, process portions, and / or blocks 802-806. At least a portion of blocks 802-806 may be performed by a fluid management system and / or one or more components thereof, such as system 100 and / or controller 140 of FIG. 1 and / or system 500 and / or controller 508 of FIG. 5A.
[0133] In block 802, method 800 includes obtaining a patient's urine conductivity. At least some aspects of block 802 may be at least generally similar to or identical to block 604 of method 600 (FIG. 6).
[0134] In block 804, method 800 includes obtaining a urinary oxygen content of the patient. At least some aspects of block 804 may be at least generally similar to or identical to block 704 of method 700 (FIG. 7).
[0135] At block 806, method 800 includes providing one or more outputs associated with the fluid therapy the patient is receiving. Typically, the one or more outputs may include, for example, one or more alerts or notifications presented to a user or physician and / or one or more modifications or adjustments to the patient's fluid therapy. One or more of the outputs may be based at least in part on the urine conductivity (block 802) and / or urine oxygen content (block 804). For example, the fluid therapy system may suggest one or more modifications to the patient's fluid therapy, e.g., to adjust or optimize therapy, maintain safety, and / or prevent harm to the patient, based at least in part on, e.g., the urine conductivity and / or modifications to be made thereto and / or the urine oxygen content and / or modifications to be made thereto. While described below as providing suggestions, those skilled in the art will recognize that in at least some embodiments, as a result of the one or more outputs, the system may automatically modify therapy, e.g., by modifying a hydration fluid compatibility level for urination, modifying a diuretic administration rate, etc., as described in the suggestions to adjust or optimize therapy.
[0136] Upon activation, if the urine oxygen content is lower than or equal to the low urine oxygen content threshold and the urine sodium concentration indication (e.g., urine conductivity) corresponds to a urine sodium concentration lower than or equal to the low urine sodium concentration threshold (e.g., 75 mmol / L), this may indicate a potentially unhealthy state of the patient's kidneys. Accordingly, one or more outputs may include a suggestion that an adjustment (e.g., a reduction) be made to the diuretic administration rate, an increase in hydration fluid compatibility, and / or therapy be discontinued. If the urine oxygen content is lower than or equal to the low urine oxygen content threshold and the urine conductivity corresponds to a urine sodium concentration equal to or higher than the high urine sodium concentration threshold (e.g., 110 mmol / L), this may also indicate a potentially unhealthy state of the patient's kidneys. Accordingly, one or more outputs may include a suggestion that an adjustment (e.g., a reduction) be made to the diuretic administration rate, an increase in hydration fluid compatibility, and / or therapy be discontinued.
[0137] Additionally or alternatively, one or more outputs may include a suggestion to increase hydration fluid suitability if the urine oxygen content is lower than or equal to a low urine oxygen content threshold and the urine conductivity corresponds to a urine sodium concentration that is between a low urine sodium concentration threshold (e.g., 75 mmol / L) and a high urine sodium concentration threshold (e.g., 100 mmol / L) and / or has a slope trending toward the low urine sodium concentration threshold. Meanwhile, a high urine oxygen concentration may indicate that the patient's kidneys are healthy, as described above herein (e.g., with reference to FIG. 7). More specifically, if the urine oxygen content is higher than or equal to a high urine oxygen content threshold and the urine conductivity corresponds to a urine sodium concentration that is lower than or equal to a low urine sodium concentration threshold (e.g., 75 mmol / L), it may indicate that the kidneys are healthy but the patient has only low urination. Thus, one or more inputs may include a suggestion to increase the diuretic administration rate, a suggestion to administer a second diuretic (e.g., a thiazide), and / or an adjustment (e.g., an increase) to make to hydration fluid compatibility.
[0138] If the urine oxygen content is greater than or equal to a high urine oxygen content threshold and the urine conductivity corresponds to a urine sodium concentration equal to or greater than a high urine sodium concentration threshold (e.g., of 100 mmol / L), the fluid therapy system may make no change to the diuretic administration rate. In some embodiments, the one or more outputs may include a suggestion to continue administering diuretic at the diuretic administration rate and / or to reduce the hydration fluid infusion rate.
[0139] If the urine oxygen content is greater than or equal to a high urine oxygen content threshold and the urine conductivity corresponds to a urine sodium concentration that is between a low urine sodium concentration threshold (e.g., 75 mmol / L) and a high urine sodium concentration threshold (e.g., 100 mmol / L) and / or has a slope trending toward a low urine sodium concentration threshold, the one or more outputs can include a suggestion to continue therapy. If the patient's urination is decreasing, the one or more outputs can include a suggestion to increase the diuretic administration rate.
[0140] 9 is a block diagram illustrating a method 900 for providing an output associated with a patient's fluid therapy based at least in part on the patient's urination (e.g., urination rate), urinary conductivity, and urinary oxygen content (e.g., urinary oxygen partial pressure) in accordance with an embodiment of the present technology. Method 900 is illustrated as a series of steps, acts, processes, process portions, and / or blocks 902-908. At least a portion of blocks 902-908 may be performed by a fluid management system and / or one or more components thereof, such as system 100 and / or controller 140 of FIG. 1 and / or system 500 and / or controller 508 of FIG. 5A.
[0141] In block 902, method 900 includes obtaining urination (e.g., urination rate) of the patient. At least some aspects of block 902 may be at least generally similar to or identical to block 602 of method 600 (FIG. 6).
[0142] At block 904, method 900 includes obtaining a urine conductivity of the patient. At least some aspects of block 904 may be at least generally similar to or identical to block 604 of method 600 (FIG. 6).
[0143] At block 906, method 800 includes obtaining a urinary oxygen content for the patient. At least some aspects of block 906 may be at least generally similar to or identical to block 704 of method 700 (FIG. 7).
[0144] At block 908, method 900 includes providing one or more outputs associated with the fluid therapy the patient is receiving. Typically, the one or more outputs may include, for example, one or more alerts or notifications presented to a user or physician and / or one or more modifications or adjustments to the patient's fluid therapy. One or more of the outputs may be based at least in part on urination (block 902), urine conductivity (block 904), and / or urine oxygen content (block 906). For example, the fluid therapy system may suggest one or more modifications to the patient's fluid therapy, e.g., to adjust or optimize treatment, maintain safety, and / or prevent harm to the patient, based at least in part on, for example, urination and / or modifications to be made thereto, urine conductivity and / or modifications to be made thereto, and / or urine oxygen content and / or modifications to be made thereto. Although described below as providing suggestions, one skilled in the art will recognize that in at least some embodiments, as a result of one or more outputs, the system can automatically modify therapy, for example, by modifying hydration fluid compatibility levels for urination, modifying diuretic administration rates, etc., as described in the suggestions to adjust or optimize therapy.
[0145] In operation, if the urine conductivity corresponds to a urine sodium concentration below or equal to a low urine sodium concentration threshold (e.g., 75 mmol / L), urination is below or equal to a low urination threshold (e.g., 325 mL / hr), and the urine oxygen content is below or equal to a low urine oxygen content threshold, the one or more outputs can include a suggestion to stop therapy and / or increase hydration fluid adequacy.If the urine conductivity corresponds to a urine sodium concentration below or equal to a low urine sodium concentration threshold (e.g., 75 mmol / L), urination is below or equal to a low urination threshold (e.g., 325 mL / hr), and the urine oxygen content is above or equal to a high urine oxygen content threshold, the one or more outputs can include a suggestion to increase the diuretic administration rate and / or administer a second diuretic (e.g., a thiazide).
[0146] If the urine conductivity corresponds to a urine sodium concentration lower than or equal to a low urine sodium concentration threshold (e.g., 75 mmol / L), urination is equal to or higher than a high urination threshold (e.g., 625 mL / hr), and the urine oxygen content is lower than or equal to the low urine oxygen content threshold, the one or more outputs can include suggestions to intensify electrolyte monitoring, reduce hydration fluid compatibility, increase diuretic administration rate, stop therapy, and / or block 908 can include providing an alert to a user, for example, regarding the patient's status. If the urine conductivity corresponds to a urine sodium concentration lower than or equal to a low urine sodium concentration threshold (e.g., 75 mmol / L), urination is equal to or higher than a high urination threshold (e.g., 625 mL / hr), and the urine oxygen content is higher than or equal to the high urine oxygen content threshold, the one or more outputs can include suggestions to intensify electrolyte monitoring.
[0147] If the urine conductivity corresponds to a urine sodium concentration below or equal to a low urine sodium concentration threshold (e.g., 75 mmol / L), urination is between the low urination threshold (e.g., 325 mL / hr) and the high urination threshold (e.g., 625 mL / hr), and the urine oxygen content is below or equal to the low urine oxygen content threshold, the one or more outputs can include a suggestion to increase electrolyte monitoring.If the urine conductivity corresponds to a urine sodium concentration below or equal to a low urine sodium concentration threshold (e.g., 75 mmol / L), urination is between the low urination threshold (e.g., 325 mL / hr) and the high urination threshold (e.g., 625 mL / hr), and the urine oxygen content is above or equal to the high urine oxygen content threshold, the one or more outputs can include a suggestion to increase the diuretic administration rate and / or administer additional diuretic.
[0148] If the urine conductivity corresponds to a urine sodium concentration equal to or greater than a high urine sodium concentration threshold (e.g., of 100 mmol / L), urination is less than or equal to a low urination threshold (e.g., of 325 mL / hr), and the urine oxygen content is less than or equal to a low urine oxygen content threshold, the one or more outputs can include a suggestion to adjust (e.g., increase) the diuretic administration rate and / or to cease therapy.If the urine conductivity corresponds to a urine sodium concentration less than or equal to a low urine sodium concentration threshold (e.g., of 75 mmol / L), urination is less than or equal to a low urination threshold (e.g., of 325 mL / hr), and the urine oxygen content is greater than or equal to a high urine oxygen content threshold, the one or more outputs can include a suggestion to increase the diuretic administration rate and / or to administer additional diuretic.
[0149] If the urine conductivity corresponds to a urine sodium concentration equal to or greater than a high urine sodium concentration threshold (e.g., of 100 mmol / L), urination is equal to or greater than a high urination threshold (e.g., of 625 mL / hr), and the urine oxygen content is less than or equal to a low urine oxygen content threshold, one or more outputs can include a suggestion to maintain (e.g., make no change to) the current therapy and / or a suggestion to increase hydration fluid compatibility, for example, to reduce or prevent sodium affinity and / or renal damage. If the urine conductivity corresponds to a urine sodium concentration equal to or greater than a high urine sodium concentration threshold (e.g., of 100 mmol / L), urination is equal to or greater than a high urination threshold (e.g., of 625 mL / hr), and the urine oxygen content is greater than or equal to the high urine oxygen content threshold, one or more outputs can include a suggestion to maintain (e.g., do not change) the current test attributes and / or a suggestion to reduce hydration fluid compatibility, for example, to increase or maximize fluid and / or salt removal.
[0150] If the urine conductivity corresponds to a urine sodium concentration equal to or greater than a high urine sodium concentration threshold (e.g., 100 mmol / L), urination is between a low urination threshold (e.g., 325 mL / hr) and a high urination threshold (e.g., 625 mL / hr), and the urine oxygen content is less than or equal to the low urine oxygen content threshold, the one or more outputs can include a suggestion to increase hydration fluid compatibility.If the urine conductivity corresponds to a urine sodium concentration equal to or greater than a high urine sodium concentration threshold (e.g., 100 mmol / L), urination is between a low urination threshold (e.g., 325 mL / hr) and a high urination threshold (e.g., 625 mL / hr), and the urine oxygen content is greater than or equal to the high urine oxygen content threshold, the one or more outputs can include a suggestion to increase the diuretic administration rate. In some embodiments, the suggestion to increase the diuretic administration rate may be in response to a decrease in urine flow rate greater than a urine flow rate reduction threshold.
[0151] III. Example Additional aspects of various embodiments of the present technology are illustrated with reference to the following examples. 1. A method of providing fluid therapy, comprising: obtaining a urine excretion rate from the patient; providing the patient with a diuretic at an infusion rate; providing a hydrating fluid to the patient at a hydration rate; obtaining one or more characteristics of the urine, including urine conductivity and / or urine oxygen content; and providing an output associated with adjusting at least one of the administration rate or the hydration rate based on the obtained characteristics of the urine; The method includes: 2. The method of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is less than a predetermined low urine sodium threshold, and urination is less than a predetermined low urination rate, providing an output includes providing an output that stops therapy, increases administration rate, and / or increases hydration rate. 3. The method of any one of the clauses herein, wherein the urine conductivity corresponds to a determined urine sodium concentration, and when the determined urine sodium concentration is greater than a predetermined high urine sodium threshold and urination is less than a predetermined low urination rate, providing an output includes providing an output that increases hydration rate, reduces diuretic administration rate, and / or stops therapy. 4. The method of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is less than a predetermined low urine sodium threshold, and the urination rate is greater than a predetermined high urination rate, providing an output includes providing an output that increases the administration rate and / or decreases the hydration rate. 5. The method of any one of the clauses herein, wherein the urine conductivity corresponds to a determined urine sodium concentration, and when the determined urine sodium concentration is greater than a predetermined high urine sodium threshold and the urination rate is greater than a predetermined high urination rate, providing an output includes providing an output that reduces the hydration rate. 6. The method of any one of the clauses herein, wherein the urine conductivity corresponds to a determined urine sodium concentration, and when the determined urine sodium concentration is greater than a predetermined high urine sodium threshold and the urination rate is decreasing, providing an output includes providing an output to increase the administration rate and / or administer additional diuretic. 7. The method of any one of the clauses herein, wherein the predetermined high urine sodium threshold is 100 millimoles (mmol) / liter (L) and the predetermined low urine sodium threshold is 75 mmol / L. 8. The method of any one of the clauses herein, wherein the predetermined low urination rate is 325 milliliters (mL) / hour (hr) and the predetermined high urination threshold is 625 mL / hr. 9. The method of any one of the clauses herein, wherein the one or more characteristics comprises urinary sodium concentration. 10. The method of any one of the clauses herein, wherein urine conductivity corresponds to a determined urine sodium concentration, and obtaining one or more characteristics of the urine includes obtaining a rate of change of the determined urine sodium concentration. 11. The method of any one of the clauses herein, wherein adjusting at least one of the administration rate or hydration rate is further based on urination rate. 12. The method of any one of the clauses herein, wherein when the urine oxygen content is less than a predetermined low urine oxygen threshold and urination is less than a predetermined low urination rate, providing an output includes providing an output that reduces the administration rate, increases the hydration rate, and / or stops therapy. 13. The method of any one of the clauses herein, wherein when the urine oxygen content is greater than a predetermined high urine oxygen threshold and urination is less than a predetermined low urination rate, providing an output includes providing an output that increases the hydration rate, increases the diuretic administration rate, and / or administers additional diuretic. 14. The method of any one of the clauses herein, wherein when the urine oxygen content is less than a predetermined low urine oxygen threshold and the urination rate is greater than a predetermined high urination rate, providing an output comprises reducing the administration rate and / or providing an output that increases the hydration rate. 15. The method of any one of the clauses herein, when the urinary oxygen content is greater than a predetermined high urinary oxygen threshold and the urination rate is decreasing, providing an output that increases the administration rate. 16. The method of any one of the clauses herein, wherein when the urine oxygen content is less than a predetermined low urine oxygen threshold and the urination rate is decreasing, providing an output includes increasing the administration rate and / or providing an output that increases the hydration rate. 17. The method of any one of the clauses herein, wherein the predetermined high urinary oxygen threshold is 25 mmHg and the predetermined low urinary oxygen threshold is 10 mmHg. 18. The method of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is less than a predetermined low urine sodium threshold, and the urine oxygen content is less than a predetermined low urine oxygen threshold, providing an output includes providing an output that reduces the administration rate and / or increases the hydration rate. 19. The method of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is greater than a predetermined high urine sodium threshold, and the urine oxygen content is less than a predetermined low urine oxygen threshold, providing an output includes providing an output that increases the hydration rate and / or reduces the diuretic administration rate. 20. The method of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is less than a predetermined low urine sodium threshold, and the urine oxygen content is greater than a predetermined high urine oxygen threshold, providing an output that increases the administration rate. 21. The method of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is greater than a predetermined high urine sodium threshold, and the urine oxygen content is also greater than a predetermined high urine oxygen threshold, providing an output includes providing an output that reduces the hydration rate. 22. The method of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the urine oxygen content is greater than a predetermined high urine oxygen threshold, and the urination rate is decreasing, providing an output that increases the administration rate. 23. A fluid therapy system comprising: a urine measurement device configured to measure urine output from a patient; a first pump configured to provide a diuretic to the patient at a diuretic administration rate; a second pump configured to provide hydration fluid to the patient at a hydration fluid infusion rate; a plurality of sensors configured to measure characteristics of urine from the patient, the sensors including a urine conductivity sensor and / or a urine oxygen sensor; one or more processors; When executed by one or more processors, obtaining a urine excretion rate from the patient by a urine measurement device; providing a diuretic to the patient at an administration rate through a first pump; providing hydration fluid to the patient at a hydration rate via a second pump; acquiring, via a sensor, one or more characteristics of the urine, including urine conductivity and / or urine oxygen content; and providing an output associated with adjusting at least one of the administration rate or the hydration rate based on the obtained urine characteristics; a tangible, non-transitory computer-readable medium having instructions for causing the fluid therapy system to perform operations including: A fluid therapy system comprising: 24. The fluid therapy system of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is less than a predetermined low urine sodium threshold, and urination is less than a predetermined low urination rate, providing an output includes providing an output that stops therapy, increases administration rate, and / or increases hydration rate. 25. The fluid therapy system of any one of the clauses herein, wherein the urine conductivity corresponds to a determined urine sodium concentration, and when the determined urine sodium concentration is greater than a predetermined high urine sodium threshold and urination is less than a predetermined low urination rate, providing an output includes providing an output that increases hydration rate, reduces diuretic administration rate, and / or stops therapy. 26. The fluid therapy system of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is less than a predetermined low urine sodium threshold, and the urination rate is greater than a predetermined high urination rate, providing an output includes providing an output that increases the administration rate and / or decreases the hydration rate. 27. The fluid therapy system of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is greater than a predetermined high urine sodium threshold, and the urination rate is greater than a predetermined high urination rate, providing an output includes providing an output that reduces the hydration rate. 28. The fluid therapy system of any one of the clauses herein, wherein the urine conductivity corresponds to a determined urine sodium concentration, and when the determined urine sodium concentration is greater than a predetermined high urine sodium threshold and the urination rate is decreasing, providing an output includes providing an output that increases the administration rate and / or administers additional diuretic. 29. The fluid therapy system of any one of the clauses herein, wherein the predetermined high urine sodium threshold is 100 millimoles (mmol) / liter (L) and the predetermined low urine sodium threshold is 75 mmol / L. 30. The fluid therapy system of any one of the clauses herein, wherein the predetermined low urination rate is 325 milliliters (mL) / hour (hr) and the predetermined high urination threshold is 625 mL / hr. 31. The fluid therapy system of any one of the clauses herein, wherein the one or more characteristics includes a urine sodium concentration. 32. The fluid therapy system of any one of clauses herein, wherein urine conductivity corresponds to a determined urine sodium concentration, and obtaining one or more characteristics of the urine includes obtaining a rate of change of the determined urine sodium concentration. 33. The fluid therapy system of any one of the clauses herein, wherein adjusting at least one of the administration rate or hydration rate is further based on a urination rate. 34. The fluid therapy system of any one of the clauses herein, wherein when the urine oxygen content is less than a predetermined low urine oxygen threshold and urination is less than a predetermined low urination rate, providing an output includes providing an output that reduces the administration rate, increases the hydration rate, and / or stops therapy. 35. The fluid therapy system of any one of the clauses herein, wherein when the urine oxygen content is greater than a predetermined high urine oxygen threshold and urination is less than a predetermined low urination rate, providing an output includes providing an output that increases the hydration rate, increases the diuretic administration rate, and / or administers additional diuretic. 36. The fluid therapy system of any one of the clauses herein, wherein when the urine oxygen content is less than a predetermined low urine oxygen threshold and the urination rate is greater than a predetermined high urination rate, providing an output includes providing an output that reduces the administration rate and / or increases the hydration rate. 37. The fluid therapy system of any one of the clauses herein, wherein when the urine oxygen content is greater than a predetermined high urine oxygen threshold and the urination rate is decreasing, providing an output includes providing an output that increases the administration rate. 38. The fluid therapy system of any one of the clauses herein, wherein when the urine oxygen content is less than a predetermined low urine oxygen threshold and the urination rate is decreasing, providing an output includes providing an output that increases the administration rate and / or increases the hydration rate. 39. The fluid therapy system of any one of the clauses herein, wherein the predetermined high urinary oxygen threshold is 25 mmHg and the predetermined low urinary oxygen threshold is 10 mmHg. 40. The fluid therapy system of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is less than a predetermined low urine sodium threshold, and the urine oxygen content is less than a predetermined low urine oxygen threshold, providing an output includes providing an output that reduces the administration rate and / or increases the hydration rate. 41. The fluid therapy system of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is greater than a predetermined high urine sodium threshold, and the urine oxygen content is less than a predetermined low urine oxygen threshold, providing an output includes providing an output that increases the hydration rate and / or reduces the diuretic administration rate. 42. The fluid therapy system of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is less than a predetermined low urine sodium threshold, and the urine oxygen content is greater than a predetermined high urine oxygen threshold, providing an output includes providing an output that increases the administration rate. 43. The fluid therapy system of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the determined urine sodium concentration is greater than a predetermined high urine sodium threshold, and the urine oxygen content is greater than a predetermined high urine oxygen threshold, providing an output includes providing an output that reduces the hydration rate. 44. The fluid therapy system of any one of the clauses herein, wherein when the urine conductivity corresponds to a determined urine sodium concentration, the urine oxygen content is greater than a predetermined high urine oxygen threshold, and the urination rate is decreasing, providing an output that increases the administration rate. 45. A urine cartridge for use with a fluid therapy system, comprising: a housing defining a fluid conduit having a first end and a second end positioned above the first end, the fluid conduit configured to receive urine from the patient at the first end and direct the received urine into the fluid line at the second end; a pair of conductive contacts defining a conductivity sensor configured to measure the conductivity of a fluid in the fluid conduit; and a temperature sensor configured to measure a temperature of the fluid in the fluid conduit; a sensor assembly including: a body configured to carry the sensor assembly and operably engage the sensor assembly and the fluid line with a fluid therapy system; Including urine cartridge. 46. The urine cartridge of any one of the clauses herein, wherein the housing of the sensor assembly further defines a plurality of sensing openings, and wherein the temperature sensor and a pair of conductive contacts are positioned at least partially within the fluid conduit through each of the plurality of sensing openings. 47. The urine cartridge of any one of the clauses herein, wherein the housing of the sensor assembly defines an interior, and the conductivity sensor and / or temperature sensor are positioned at least partially within the interior. 48.1 The urine cartridge of any one of the clauses herein, wherein the pairs of conductive contacts are spaced apart from each other by a distance of at least 0.44 inches. 49. The main body is a urine line coupling feature configured to couple to a first portion of the fluid line and direct urine flow through the first portion in a first direction; a urine line return feature configured to couple to a second portion of the fluid line and direct urine flow through the second portion in a second direction opposite the first direction; Including, Any one urine cartridge as herein provided. 50. The urine cartridge of any one of the clauses herein, wherein the fluid conduit has a first inner diameter and the fluid line has a second inner diameter different from the first inner diameter. 51. The urine cartridge of any one of the clauses herein, wherein the fluid conduit has a first inner diameter and the fluid line has a second inner diameter that is smaller than the first inner diameter. 52. The urine cartridge of any one of the clauses herein, wherein the temperature sensor is positioned between a pair of conductive contacts. 53. The main body, a urine line coupling feature configured to couple to a first portion of the fluid line and direct urine flow in a vertically upward direction through the first portion; a urine line return feature configured to couple to the second portion of the fluid line and direct urine flow vertically downward through the second portion; Including, Any one urine cartridge as herein provided. 54. A proximal fluid line configured to receive urine from the patient; a distal fluid line configured to direct received urine to a container; a urine flow assembly including a sensor configured to generate sensor data based on received urine; a body configured to (i) couple to a portion of the distal fluid line, (ii) couple to the urine flow assembly, and (iii) operably engage the portion of the distal fluid line with a sensor when coupled to the urine flow assembly; and Sensor assembly, A urine cartridge comprising: The sensor assembly a housing defining (i) a fluid conduit coupled to the proximal fluid line for receiving urine from the patient through the proximal fluid line; and (ii) a fluid conduit coupled to the distal fluid line and configured to direct the received urine through the distal fluid line toward a container; a pair of conductive contacts defining a conductivity sensor configured to measure the conductivity of a fluid in the fluid conduit; and a temperature sensor positioned generally adjacent to the pair of conductive contacts and configured to measure a temperature of the fluid in the fluid conduit; Including, The urine cartridge; A fluid therapy system comprising: 55. The fluid therapy system of any one of the clauses herein, wherein the sensor defines a slot and the body of the urine cartridge is configured to position a portion of the distal fluid line within the slot when coupled to the urine flow assembly. 56. The fluid therapy system of any one of the clauses herein, wherein the urine flow assembly includes a receiving feature, and the body of the urine cartridge includes a coupling feature configured to releasably engage the receiving feature and to operably engage a portion of the distal fluid line with the sensor. 57. The fluid therapy system of any one of the clauses herein, wherein the portion of the distal fluid line is an upstream portion of the distal fluid line, and wherein the body of the urine cartridge defines a channel configured to receive the downstream portion of the distal fluid line. 58. The fluid therapy system of any one of the clauses herein, wherein the fluid conduit has a first inner diameter and the proximal fluid line and / or the distal fluid line have a second inner diameter that is smaller than the first inner diameter. 59. The fluid therapy system of any one of the clauses herein, wherein the temperature sensor is positioned upstream or downstream of one or both of a pair of conductive contacts. 60. A first pump configured to provide a diuretic to the patient at a diuretic administration rate; a second pump configured to provide hydration fluid to the patient at a hydration fluid infusion rate; one or more processors; When executed by one or more processors, obtaining a urine excretion rate from the patient via a sensor; providing a diuretic to the patient at an administration rate through a first pump; providing hydration fluid to the patient at a hydration rate via a second pump; acquiring one or more characteristics of the urine, including urine conductivity, via a conductivity sensor and / or a temperature sensor; and providing an output associated with adjusting at least one of the administration rate or the hydration rate based on the obtained urine characteristics; a tangible, non-transitory computer-readable medium having instructions for causing the fluid therapy system to perform operations including: 10. The fluid therapy system of any one of the clauses herein further comprising: 61. A method of providing fluid therapy, comprising: providing a diuretic to the patient through the first pump at a diuretic administration rate; providing hydration fluid to the patient at a hydration rate via a second pump; receiving urine from the patient through a proximal fluid line at a first end of a fluid conduit of the sensor assembly; acquiring one or more properties of urine in the fluid conduit via a conductivity sensor and / or a temperature sensor of the sensor assembly; directing urine from a second end of the fluid conduit positioned above the first end through a distal fluid line toward a container; and providing an output associated with adjusting the diuretic administration rate and / or hydration rate based on the obtained urine characteristics; A method comprising: 62. The method of any one of the clauses herein, wherein directing urine to flow out of the second end of the fluid conduit includes directing urine to flow through an upstream portion of the distal fluid line in a first direction, and the method further includes directing urine to flow through a downstream portion of the distal fluid line in a second direction opposite the first direction. 63. The method of any one of the clauses herein, further comprising at least partially receiving the upstream portion of the distal fluid line within one or more urine line coupling features of a urine cartridge including the sensor assembly. 64. The method of any one of the clauses herein, wherein the conductivity sensor includes a pair of conductive contacts, and acquiring the one or more characteristics includes acquiring the temperature of the urine between the pair of conductive contacts via a temperature sensor. 65. The method of any one of the clauses herein, wherein adjusting the diuretic administration rate and / or hydration rate comprises increasing or decreasing the diuretic administration rate and / or hydration rate. 66. The method of any one of the clauses herein, further comprising, prior to receiving urine from the patient, rinsing the sensor assembly with a solution of known electrolyte content to calibrate the conductivity sensor.
[0152] IV. conclusion It will be apparent to those skilled in the art that changes can be made to the details of the above-described embodiments without departing from the principles underlying the present technology. In some instances, well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of embodiments of the present technology. While blocks of the method may be provided herein in a particular order, alternative embodiments may perform these blocks in a different order. Similarly, certain aspects of the present technology that are disclosed in the context of a particular embodiment may be combined or eliminated in other embodiments. Furthermore, while advantages associated with certain embodiments of the present technology may be disclosed in the context of that embodiment, other embodiments may exhibit such advantages, and not all embodiments necessarily exhibit such advantages or other advantages disclosed herein to fall within the present technology. Therefore, the present disclosure and related technology may encompass other embodiments not expressly shown or described herein, and the present invention is not limited except as limited by the claims.
[0153] Unless the context clearly dictates otherwise throughout this disclosure, the singular forms "a," "an," and "the" include plural referents. The use of the term "and / or" in connection with a list consisting of two or more items shall be construed as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. In addition, the terms "comprising," "including," and "having" shall be construed as including at least the recited features, and thus not excluding any greater number of the same feature and / or other features of additional types.
[0154] References herein to "one embodiment," "embodiments," "some embodiments," or similar phrases mean that a particular feature, structure, operation, or characteristic described in connection with that embodiment may be included in at least one embodiment of the present technology. Thus, appearances of such phrases or phrases herein are not necessarily all referring to the same embodiment. Furthermore, various particular features, structures, operations, or characteristics may be combined in any suitable manner in one or more embodiments.
[0155] Unless otherwise indicated, all numbers expressing concentrations, pressures, and other numerical values used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and claims are approximations that may vary depending on the desired properties sought to be obtained by the techniques of the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of significant digits disclosed and by applying ordinary rounding techniques. Additionally, all ranges disclosed herein are to be understood to encompass any and all subranges subsumed within that range. For example, the range "1 to 10" includes any and all subranges between (and including) a minimum value of 1 and a maximum value of 10, i.e., any and all subranges having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10, such as 5.5 to 10.
[0156] The above-set forth disclosure of the present invention is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Instead, as the following claims reflect, inventive aspects lie in combinations of fewer than all features of any one of the foregoing disclosed embodiments. Accordingly, the claims following the Detailed Description are expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. The present disclosure includes all permutations of independent claims with their dependent claims. [Explanation of symbols]
[0157] 501 Urine Cartridge 519' Proximal Fluid Line 565a First urine line connection feature 567a First urine line return feature 570 Sensor Assembly
Claims
1. 1. A urine cartridge for use with a fluid therapy system, comprising: a housing defining a fluid conduit having a first end and a second end positioned above the first end, the fluid conduit configured to receive urine from a patient at the first end and direct the received urine into a fluid line at the second end; a pair of conductive contacts defining a conductivity sensor configured to measure the conductivity of a fluid in the fluid conduit; and a temperature sensor configured to measure a temperature of fluid in the fluid conduit; a sensor assembly including: a body configured to carry the sensor assembly and operably engage the sensor assembly and the fluid line with the fluid therapy system; Including urine cartridge.
2. the housing of the sensor assembly further defines a plurality of sensing apertures; the temperature sensor and the pair of conductive contacts are positioned at least partially within the fluid conduit through a respective one of the plurality of sensing openings; The urine cartridge according to claim 1.
3. the housing of the sensor assembly defines an interior; the conductivity sensor and / or the temperature sensor are positioned at least partially within the interior; The urine cartridge according to claim 1.
4. 10. The urine cartridge of claim 1, wherein the pairs of conductive contacts are spaced apart from each other by a distance of at least 0.44 inches.
5. The body includes: a urine line coupling feature configured to couple to a first portion of the fluid line and direct urine flow through the first portion in a first direction; a urine line return feature configured to couple to a second portion of the fluid line and direct urine flow through the second portion in a second direction opposite the first direction; Including, The urine cartridge according to claim 1.
6. the fluid conduit has a first inner diameter; the fluid line has a second inner diameter different from the first inner diameter; The urine cartridge according to claim 1.
7. the fluid conduit has a first inner diameter; the fluid line has a second inner diameter smaller than the first inner diameter; The urine cartridge according to claim 1.
8. The urine cartridge of claim 1 , wherein the temperature sensor is positioned between the pair of conductive contacts.
9. The body includes: a urine line coupling feature configured to couple to a first portion of the fluid line and direct urine flow in a vertically upward direction through the first portion; a urine line return feature configured to couple to a second portion of the fluid line and direct urine flow vertically downward through the second portion; Including, The urine cartridge according to claim 1.
10. 1. A fluid therapy system comprising: a proximal fluid line configured to receive urine from the patient; a distal fluid line configured to direct the received urine to a container; a urine flow assembly including a sensor configured to generate sensor data based on the received urine; a urine cartridge including a body configured to (i) couple to a portion of the distal fluid line, (ii) couple to the urine flow assembly, and (iii) operably engage the portion of the distal fluid line with the sensor when coupled to the urine flow assembly; and a sensor assembly; Including, the sensor assembly (i) a housing coupled to the proximal fluid line to receive urine from the patient through the proximal fluid line, and (ii) a housing defining a fluid conduit coupled to the distal fluid line and configured to direct the received urine through the distal fluid line to the container; a pair of conductive contacts defining a conductivity sensor configured to measure the conductivity of a fluid in the fluid conduit; a temperature sensor positioned generally adjacent the pair of conductive contacts and configured to measure a temperature of fluid within the fluid conduit; A fluid therapy system comprising:
11. the sensor defines a slot; the body of the urine cartridge is configured to position the portion of the distal fluid line within the slot when coupled to the urine flow assembly; The fluid therapy system of claim 10.
12. the urine flow assembly includes a receiving feature; the body of the urine cartridge includes a mating feature configured to releasably engage the receiving feature to operably engage the portion of the distal fluid line with the sensor. The fluid therapy system of claim 10.
13. the portion of the distal fluid line is an upstream portion of the distal fluid line; the body of the urine cartridge defines a channel configured to receive a downstream portion of the distal fluid line; The fluid therapy system of claim 10.
14. the fluid conduit has a first inner diameter; the proximal fluid line and / or the distal fluid line have a second inner diameter smaller than the first inner diameter; The fluid therapy system of claim 10.
15. 11. The fluid therapy system of claim 10, wherein the temperature sensor is positioned upstream or downstream from one or both of the pairs of conductive contacts.
16. a first pump configured to provide a diuretic to the patient at a diuretic administration rate; a second pump configured to provide hydration fluid to the patient at a hydration fluid infusion rate; one or more processors; When executed by the one or more processors, obtaining a urine excretion rate from the patient through said sensor; providing a diuretic to the patient at an administration rate through the first pump; providing a hydration fluid to the patient at a hydration rate through the second pump; obtaining one or more properties of the urine, including urine conductivity, through the conductivity sensor and / or the temperature sensor; and providing an output associated with adjusting at least one of the administration rate or the hydration rate based on the obtained characteristics of the urine; a tangible, non-transitory computer-readable medium having instructions for causing the fluid therapy system to perform operations including: The fluid therapy system of claim 10 further comprising:
17. 1. A method of providing fluid therapy, comprising: providing a diuretic to the patient via the first pump at a diuretic administration rate; providing a hydration fluid to said patient at a hydration rate via a second pump; receiving urine from the patient through a proximal fluid line at a first end of the fluid conduit of the sensor assembly; obtaining one or more properties of the urine in the fluid conduit via a conductivity sensor and / or a temperature sensor of the sensor assembly; directing the urine through a distal fluid line toward a container and out a second end of the fluid conduit, the second end being positioned above the first end; and providing an output associated with adjusting the diuretic administration rate and / or the hydration rate based on the obtained characteristics of the urine; A method comprising:
18. directing the urine to flow out the second end of the fluid conduit includes directing the urine to flow in a first direction through an upstream portion of the distal fluid line; the method further comprising directing the urine to flow in a second direction opposite the first direction through a downstream portion of the distal fluid line.
18. The method of claim 17.
19. 18. The method of claim 17, further comprising at least partially receiving an upstream portion of the distal fluid line within one or more urine line coupling features of a urine cartridge that includes the sensor assembly.
20. the conductivity sensor includes a pair of conductive contacts; obtaining the one or more characteristics includes obtaining a temperature of the urine between the pair of conductive contacts via the temperature sensor.
18. The method of claim 17.
21. 18. The method of claim 17, wherein adjusting the diuretic administration rate and / or the hydration rate comprises increasing or decreasing the diuretic administration rate and / or the hydration rate.
22. 18. The method of claim 17, further comprising washing the sensor assembly with a solution of known electrolyte content to calibrate the conductivity sensor before receiving the urine from the patient.
Citation Information
Patent Citations
US11,633,137